Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Applanation Tonometer

K-Number: K142263 · 2016-04-15

ApplicantShanghai Mediworks Precision Instruments Co. , Ltd.
Decision Date2016-04-15
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Applanation Tonometer is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Mediworks Precision Instruments Co. , Ltd.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) 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. The listed applicant is Shanghai Mediworks Precision Instruments Co. , Ltd.. The 510(k) number is K142263.

When did Applanation Tonometer receive FDA 510(k) clearance?

Applanation Tonometer received FDA 510(k) clearance on 2016-04-15, under 510(k) number K142263.

Who is the listed applicant for Applanation Tonometer?

The FDA 510(k) record lists Shanghai Mediworks Precision Instruments Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Applanation Tonometer?

The FDA product code for Applanation Tonometer is HKY.

Related Clinical Trials

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.

NCT04639947Reliability and Reproducibility of the Eye Check TonometerTERMINATED

Other records listing Shanghai Mediworks Precision Instruments Co. , Ltd. as applicant

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.

K152429Slit Lamp Microscope

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.

↑