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

FDA 510(k)

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

K-Number: K191314 · 2019-12-19

ApplicantChongqing Sunkingdom Medical Instrument Co., Ltd.
Decision Date2019-12-19
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q is a medical device manufactured by Chongqing Sunkingdom Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under approval number K191314. 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 Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q?

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Chongqing Sunkingdom Medical Instrument Co., Ltd.. The 510(k) number is K191314.

When was Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q approved by the FDA?

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q received FDA 510(k) clearance on 2019-12-19, under approval number K191314.

What company makes Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q?

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q is manufactured by Chongqing Sunkingdom Medical Instrument Co., Ltd..

What is the FDA product code for Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q?

The FDA product code for Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q is HKY.

Related Clinical Trials

NCT05523622 Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices RECRUITING NCT04639947 Reliability and Reproducibility of the Eye Check Tonometer TERMINATED

Other Devices by Chongqing Sunkingdom Medical Instrument Co., Ltd.

K182306Sunkingdom Slit Lamp K222787Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P

Related Devices (Code: HKY)

K153694Icare ic100Icare Finland OY K142263Applanation TonometerShanghai Mediworks Precision Instruments Co. , Ltd. K151491Falck Medical Multifunction Tonometer, FAT1Falck Medical, Inc. K172728Applanation tonometer AT-1Takagi Seiko Co., Ltd. K163343Icare HOME tonometerIcare Finland OY K182491Applanation tonometer AT-2Takagi Seiko Co., Ltd.

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.

↑