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FDA 510(k)

WELCH ALLYN 11800 OPTHALMOSCOPE

K-Number: K003376 · 2001-01-25

ApplicantWelch Allyn, Inc.
Decision Date2001-01-25
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN 11800 OPTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2001-01-25 under 510(k) number K003376. 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 WELCH ALLYN 11800 OPTHALMOSCOPE?

WELCH ALLYN 11800 OPTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K003376.

When did WELCH ALLYN 11800 OPTHALMOSCOPE receive FDA 510(k) clearance?

WELCH ALLYN 11800 OPTHALMOSCOPE received FDA 510(k) clearance on 2001-01-25, under 510(k) number K003376.

Who is the listed applicant for WELCH ALLYN 11800 OPTHALMOSCOPE?

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

What is the FDA product code for WELCH ALLYN 11800 OPTHALMOSCOPE?

The FDA product code for WELCH ALLYN 11800 OPTHALMOSCOPE is HLI.

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Other records listing Welch Allyn, Inc. as applicant

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Related Devices (Code: 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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