FDA 510(k)

EXOPHTHALMOMETER

K-Number: K821107 · 1982-06-14

ApplicantMedical Equipment Designs, Inc.

Decision Date1982-06-14

Product CodeHCS

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EXOPHTHALMOMETER 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 1982-06-14 under 510(k) number K821107. The device is classified under product code HCS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXOPHTHALMOMETER?

EXOPHTHALMOMETER is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Medical Equipment Designs, Inc.. The 510(k) number is K821107.

When did EXOPHTHALMOMETER receive FDA 510(k) clearance?

EXOPHTHALMOMETER received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821107.

Who is the listed applicant for EXOPHTHALMOMETER?

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 EXOPHTHALMOMETER?

The FDA product code for EXOPHTHALMOMETER is HCS.

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Related Devices (Code: HCS)

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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.