PATH medical GmbH

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Auditory, Evoked Response (GWJ) (10) Audiometer (EWO) (7)

Premarket Exempt

No Yes

Clear

Headphone HDA 280 - 04260223140372 Catalog Number :

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Headphone PD-81 - 04260223140389 Catalog Number :

Device Description : Headphone PD-81, HP-05, calibrated

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Accessory Box AB01 - 04260223140716 Catalog Number :

Device Description : Accessory set including: 5 pcs. 100013 Probe Tip PT-A1 pcs. 100129 Test Cavity10 Accessory set including: 5 pcs. 100013 Probe Tip PT-A1 pcs. 100129 Test Cavity10 pcs. 100063 Ear Tip ET-0310 pcs. 100064 Ear Tip ET-107 pcs. 100125 Ear Tip ET-1112 pcs. 100126 Ear Tip Soft ET-S127 pcs. 100230 Ear Tip Soft ET-S147 pcs. 100144 Ear Tip ET-132pcs. 100151 Cleaning Tool CT-01

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

Accessory Box AB02 - 04260223140723 Catalog Number :

Device Description : Accessory set including:1 pc. 100013 Probe Tip PT-A1 pc. 100219 Test Cavity for Accessory set including:1 pc. 100013 Probe Tip PT-A1 pc. 100219 Test Cavity for PT-A5pcs. 100063 Ear Tip ET-035pcs. 100064 Ear Tip ET-105pcs. 100125 Ear Tip ET-115pcs. 100126 Ear Tip Soft ET-125pcs. 100144 Ear Tip ET-133pcs. 100230 Ear Tip Soft ET-141pc 100151 Cleaning Tool CT-01

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

Accessory box AB03 - 04260223140730 Catalog Number :

Device Description : Accessory Set including:4pcs. 100013 Probe Tip PT-A4pcs. 100014-W Probe Tip PT-S Accessory Set including:4pcs. 100013 Probe Tip PT-A4pcs. 100014-W Probe Tip PT-S1pc. 100129 Test Cavity PT-A1pc. 100160 Test Cavity PT-S10pcs. 100063 Ear Tip ET-0310pcs. 100064 Ear Tip ET-107pcs 100125 Ear Tip ET-115pcs. 100839 Ear Tip Soft ET-176pcs. 100838 Ear Tip Soft ET-1610pcs. 100144 Ear Tip ET-134pcs. 100230 Ear Tip Soft ET-1410pcs. 100030 Ear Tip ET-S0210pcs. 100031 Ear Tip ET-S0310pcs. 100032 Ear Tip ET-S1010pcs. 100840 Ear Tip Soft ET-S111pc. 100151 Cleaning Tool CT-01

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

Headphone DD-45 - 04260223140761 Catalog Number :

Device Description : DD-45 headphone

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Insert Earphone otoInsert - 04260223140822 Catalog Number :

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Patient Response Button - 04260223140860 Catalog Number :

Device Description : Patient response button for Sentiero

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

Patient Response Button - 04260223140877 Catalog Number :

Device Description : Patient response button for Sentiero Advanced

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

Patient Response Button - 04260223140884 Catalog Number :

Device Description : Patient response button.PATH MEDICAL is not manufacturer or Labeler of this prod Patient response button.PATH MEDICAL is not manufacturer or Labeler of this product. This Product was uploaded to GUDID erroneously by PATH MEDICAL.

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

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