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FDA 510(k)

DISPOSABLE DIAPHRAGM DOMES

K-Number: K820355 · 1982-03-04

ApplicantMedex, Inc.
Decision Date1982-03-04
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE DIAPHRAGM DOMES is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K820355. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE DIAPHRAGM DOMES?

DISPOSABLE DIAPHRAGM DOMES is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Medex, Inc.. The 510(k) number is K820355.

When did DISPOSABLE DIAPHRAGM DOMES receive FDA 510(k) clearance?

DISPOSABLE DIAPHRAGM DOMES received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820355.

Who is the listed applicant for DISPOSABLE DIAPHRAGM DOMES?

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

What is the FDA product code for DISPOSABLE DIAPHRAGM DOMES?

The FDA product code for DISPOSABLE DIAPHRAGM DOMES is DRS.

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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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