FALCK MEDICAL INC

FALCK MEDICAL INC

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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

Tonometer, Manual (HKY) (2)

Premarket Exempt

No

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Falck Medical Multi-Function Applanation Tonometer - 00867009000208 Catalog Number :

Device Description : Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodyna Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement

Device Class : 2

Duns Number: 010283033

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

FMAT1 Prism B - 00867009000215 Catalog Number :

Device Description : Disposable single use prism for FMAT1 Device

Device Class :

Duns Number: 010283033

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

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