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FDA 510(k)

SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE

K-Number: K951728 · 1997-03-19

ApplicantMira, Inc.
Decision Date1997-03-19
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Mira, Inc.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K951728. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE?

SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Mira, Inc.. The 510(k) number is K951728.

When did SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE receive FDA 510(k) clearance?

SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE received FDA 510(k) clearance on 1997-03-19, under 510(k) number K951728.

Who is the listed applicant for SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE?

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

What is the FDA product code for SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE?

The FDA product code for SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE is HLI.

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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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