IMDK

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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

Oximeter, Infrared, Sporting, Aviation (OCH) (5) Monitor, Ultrasonic, Fetal (KNG) (2)

Premarket Exempt

No Yes

Clear

IMDK - 06973912940013 Catalog Number :

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 544547964

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

IMDK - 06973912940020 Catalog Number :

Device Description : Ultrasonic Doppler Fetal Heart Rate Detector

Device Class : 2

Duns Number: 544547964

Premarket Exempt : No

Product Code : KNG

Prescription Use : No

Device Count : 1

IMDK - 06973912940037 Catalog Number :

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 544547964

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

IMDK - 06973912940044 Catalog Number :

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 544547964

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

IMDK - 06973912940051 Catalog Number :

Device Description : Ultrasonic Doppler Fetal Heart Rate Detector

Device Class : 2

Duns Number: 544547964

Premarket Exempt : No

Product Code : KNG

Prescription Use : No

Device Count : 1

IMDK - 06973912940068 Catalog Number :

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 544547964

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

IMDK - 06973912940075 Catalog Number :

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 544547964

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

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