SAFEY MEDICAL DEVICES PRIVATE LIMITED

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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

Meter, Peak Flow, Spirometry (BZH) (1) Spirometer, Diagnostic (BZG) (1)

Premarket Exempt

Clear

Safey Pocket Spirometer - 08908014292003 Catalog Number :

Device Description : Safey Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Ph Safey Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. Safey Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment and Professional Healthcare Environment.

Device Class : 2

Duns Number: 878291677

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Safey Peak Flow Meter - 08908014292010 Catalog Number :

Device Description : Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forc Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.The device is designed for children greater than five years of age, adolescent and adult subjects.

Device Class : 2

Duns Number: 878291677

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

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