FDA 510(k)

AUDIOMETER MODEL MD-4, MD-4P

K-Number: K895785 · 1989-12-05

Decision Date1989-12-05

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

AUDIOMETER MODEL MD-4, MD-4P is the device name listed in this FDA 510(k) record. The listed applicant is Singer Medical Products, Inc.. It received FDA 510(k) clearance on 1989-12-05 under 510(k) number K895785. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIOMETER MODEL MD-4, MD-4P?

AUDIOMETER MODEL MD-4, MD-4P is a medical device that received FDA 510(k) clearance on 1989-12-05. The listed applicant is Singer Medical Products, Inc.. The 510(k) number is K895785.

When did AUDIOMETER MODEL MD-4, MD-4P receive FDA 510(k) clearance?

AUDIOMETER MODEL MD-4, MD-4P received FDA 510(k) clearance on 1989-12-05, under 510(k) number K895785.

Who is the listed applicant for AUDIOMETER MODEL MD-4, MD-4P?

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

What is the FDA product code for AUDIOMETER MODEL MD-4, MD-4P?

The FDA product code for AUDIOMETER MODEL MD-4, MD-4P is EWO.

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Other records listing Singer Medical Products, 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.