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FDA 510(k)

Falck Medical Multifunction Tonometer, FAT1

K-Number: K151491 · 2016-01-15

ApplicantFalck Medical, Inc.
Decision Date2016-01-15
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: HKY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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