Braebon Medical Corporation

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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

No Yes

Clear

BRAEBON 1-Foot Double Loop Effort Belt - B140052310 Catalog Number : 0523-1

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 2-Foot Double Loop Effort Belt - B140052320 Catalog Number : 0523-2

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 3-Foot Double Loop Effort Belt - B140052330 Catalog Number : 0523-3

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 4-Foot Double Loop Effort Belt - B140052340 Catalog Number : 0523-4

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 5-Foot Double Loop Effort Belt - B140052350 Catalog Number : 0523-5

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 1-Foot Double Buckle Effort Belt - B140052610 Catalog Number : 0526-1

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 2-Foot Double Buckle Effort Belt - B140052620 Catalog Number : 0526-2

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 3-Foot Double Buckle Effort Belt - B140052630 Catalog Number : 0526-3

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 4-Foot Double Buckle Effort Belt - B140052640 Catalog Number : 0526-4

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

BRAEBON 5-Foot Double Buckle Effort Belt - B140052650 Catalog Number : 0526-5

Device Description : Belt for use with PVDF Respiratory effort sensor..

Device Class : 2

Duns Number: 251731105

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

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