DYMEDIX DIAGNOSTICS, INC.

Address:5985 Rice Creek Pkwy Ste 200,Shoreview,MN,55126,US

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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

Monitor, Breathing Frequency (BZQ) (10)

Premarket Exempt

Clear

Perfect Fit - 00817377020407 Catalog Number :

Device Description : Perfect Fit™Adult Effort Belt Sensor, Abdomen

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020414 Catalog Number :

Device Description : Perfect Fit™ II Adult Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020421 Catalog Number :

Device Description : Perfect Fit II Adult Effort Belt Sensor, Chest, Alice 5

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020438 Catalog Number :

Device Description : Perfect Fit II Adult Effort Belt Sensor, Chest, Alice 3

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020445 Catalog Number :

Device Description : Perfect Fit™ II R/S Adult Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020452 Catalog Number :

Device Description : Perfect Fit ™II Adult Effort Belt Sensor, Abdomen

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020469 Catalog Number :

Device Description : Perfect Fit ™II Adult Effort Belt Sensor, Abdomen, Alice 5

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020476 Catalog Number :

Device Description : Perfect Fit ™II Adult Effort Belt Sensor, Abdomen, Alice 3

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020483 Catalog Number :

Device Description : Perfect Fit™ II R/S Adult Effort Belt Sensor, Abdomen

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020490 Catalog Number :

Device Description : Cadwell ApneaTrak Adult Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

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