FDA 510(k)

Falck Medical Multifunction Tonometer, FAT1

Número K: K151491 · 2016-01-15

Data da decisão2016-01-15

Código do produtoHKY

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Falck Medical Multifunction Tonometer, FAT1 is the device name listed in this FDA 510(k) record. The listed applicant is Falck Medical, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151491. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Falck Medical Multifunction Tonometer, FAT1?

Falck Medical Multifunction Tonometer, FAT1 is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Falck Medical, Inc.. The 510(k) number is K151491.

When did Falck Medical Multifunction Tonometer, FAT1 receive FDA 510(k) clearance?

Falck Medical Multifunction Tonometer, FAT1 received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151491.

Who is the listed applicant for Falck Medical Multifunction Tonometer, FAT1?

The FDA 510(k) record lists Falck Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Falck Medical Multifunction Tonometer, FAT1?

The FDA product code for Falck Medical Multifunction Tonometer, FAT1 is HKY.

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Fonte oficial

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