Applanation Tonometer
K-Number: K142263 · 2016-04-15
Decision Date2016-04-15
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Applanation Tonometer is a medical device manufactured by Shanghai Mediworks Precision Instruments Co. , Ltd.. It received FDA 510(k) clearance on 2016-04-15 under approval number K142263. 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 Applanation Tonometer?
Applanation Tonometer is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Shanghai Mediworks Precision Instruments Co. , Ltd.. The 510(k) number is K142263.
When was Applanation Tonometer approved by the FDA?
Applanation Tonometer received FDA 510(k) clearance on 2016-04-15, under approval number K142263.
What company makes Applanation Tonometer?
Applanation Tonometer is manufactured by Shanghai Mediworks Precision Instruments Co. , Ltd..
What is the FDA product code for Applanation Tonometer?
The FDA product code for Applanation Tonometer is HKY.
Related Clinical Trials
Other Devices by Shanghai Mediworks Precision Instruments Co. , Ltd.
Related Devices (Code: HKY)
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.