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FDA 510(k)

ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)

K-Number: K912581 · 1991-12-23

ApplicantCarl Zeiss, Inc.
Decision Date1991-12-23
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) 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 1991-12-23 under 510(k) number K912581. 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 ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)?

ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K912581.

When did ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) receive FDA 510(k) clearance?

ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) received FDA 510(k) clearance on 1991-12-23, under 510(k) number K912581.

Who is the listed applicant for ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)?

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 CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)?

The FDA product code for ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) is HLI.

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Other records listing Carl Zeiss, Inc. as applicant

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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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