FDA 510(k)

HAND KERATOSCOPE

K-Number: K821080 · 1982-05-24

ApplicantMedical Equipment Designs, Inc.

Decision Date1982-05-24

Product CodeHLR

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

HAND KERATOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Designs, Inc.. It received FDA 510(k) clearance on 1982-05-24 under 510(k) number K821080. 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 HAND KERATOSCOPE?

HAND KERATOSCOPE is a medical device that received FDA 510(k) clearance on 1982-05-24. The listed applicant is Medical Equipment Designs, Inc.. The 510(k) number is K821080.

When did HAND KERATOSCOPE receive FDA 510(k) clearance?

HAND KERATOSCOPE received FDA 510(k) clearance on 1982-05-24, under 510(k) number K821080.

Who is the listed applicant for HAND KERATOSCOPE?

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

What is the FDA product code for HAND KERATOSCOPE?

The FDA product code for HAND KERATOSCOPE is HLR.

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Other records listing Medical Equipment Designs, Inc. as applicant

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Related Devices (Code: HLR)

K901553SURG-K SURGICAL KERATOMETERThe Sanborn Co.K882902QRK 100, QUALITATIVE RING KERATOSCOPETechnitex, Inc.K882618JEDMED/POLACK KERATOSCOPE HS/SLGamut Ent.K864639REUSABLE SURGICAL KERATOSCOPEJedmed Instrument Co.K854054PLACIDO DISCCutler Medical Instruments K830008KARICKHOFF KERATOSCOPESurgidev Corp.

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.