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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 the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Sunkingdom Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) 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. The listed applicant is Chongqing Sunkingdom Medical Instrument Co., Ltd.. The 510(k) number is K191314.

When did Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q receive FDA 510(k) clearance?

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

Who is the listed applicant for Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q?

The FDA 510(k) record lists Chongqing Sunkingdom Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Chongqing Sunkingdom Medical Instrument 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.

K222787Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000PK182306Sunkingdom Slit Lamp

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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