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FDA 510(k)

QRK 100, QUALITATIVE RING KERATOSCOPE

K-Number: K882902 · 1988-08-04

ApplicantTechnitex, Inc.
Decision Date1988-08-04
Product CodeHLR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

QRK 100, QUALITATIVE RING KERATOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Technitex, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K882902. The device is classified under product code HLR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QRK 100, QUALITATIVE RING KERATOSCOPE?

QRK 100, QUALITATIVE RING KERATOSCOPE is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Technitex, Inc.. The 510(k) number is K882902.

When did QRK 100, QUALITATIVE RING KERATOSCOPE receive FDA 510(k) clearance?

QRK 100, QUALITATIVE RING KERATOSCOPE received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882902.

Who is the listed applicant for QRK 100, QUALITATIVE RING KERATOSCOPE?

The FDA 510(k) record lists Technitex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QRK 100, QUALITATIVE RING KERATOSCOPE?

The FDA product code for QRK 100, QUALITATIVE RING KERATOSCOPE is HLR.

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.

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Other records listing Technitex, Inc. 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.

K893968VKG 2000 VIDEO KERATOMETERK883471VKG 1000, VIDEO KERATOMETER

Related Devices (Code: HLR)

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.

K901553SURG-K SURGICAL KERATOMETERThe Sanborn Co.K882618JEDMED/POLACK KERATOSCOPE HS/SLGamut Ent.K864639REUSABLE SURGICAL KERATOSCOPEJedmed Instrument Co.K854054PLACIDO DISCCutler Medical InstrumentsK830008KARICKHOFF KERATOSCOPESurgidev Corp.K821080HAND KERATOSCOPEMedical Equipment Designs, Inc.

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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