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FDA 510(k)

ZEISS OPMI L STEREO-LAPAROSCOPE

K-Number: K931478 · 1994-09-28

ApplicantCarl Zeiss, Inc.
Decision Date1994-09-28
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ZEISS OPMI L STEREO-LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1994-09-28 under 510(k) number K931478. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEISS OPMI L STEREO-LAPAROSCOPE?

ZEISS OPMI L STEREO-LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K931478.

When did ZEISS OPMI L STEREO-LAPAROSCOPE receive FDA 510(k) clearance?

ZEISS OPMI L STEREO-LAPAROSCOPE received FDA 510(k) clearance on 1994-09-28, under 510(k) number K931478.

Who is the listed applicant for ZEISS OPMI L STEREO-LAPAROSCOPE?

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

What is the FDA product code for ZEISS OPMI L STEREO-LAPAROSCOPE?

The FDA product code for ZEISS OPMI L STEREO-LAPAROSCOPE is HET.

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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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