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 a medical device manufactured by Falck Medical, Inc.. It received FDA 510(k) clearance on 2016-01-15 under approval 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. It is manufactured by Falck Medical, Inc.. The 510(k) number is K151491.
When was Falck Medical Multifunction Tonometer, FAT1 approved by the FDA?
Falck Medical Multifunction Tonometer, FAT1 received FDA 510(k) clearance on 2016-01-15, under approval number K151491.
What company makes Falck Medical Multifunction Tonometer, FAT1?
Falck Medical Multifunction Tonometer, FAT1 is manufactured by Falck Medical, Inc..
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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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.