FDA 510(k)

IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P

K-Number: K894748 · 1989-12-05

Decision Date1989-12-05

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P 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 K894748. 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 IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P?

IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P 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 K894748.

When did IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P receive FDA 510(k) clearance?

IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P received FDA 510(k) clearance on 1989-12-05, under 510(k) number K894748.

Who is the listed applicant for IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P?

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 IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P?

The FDA product code for IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P is EWO.

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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.