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FDA 510(k)

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY

K-Number: K950888 · 1995-03-21

ApplicantCalmed Technology, Inc.
Decision Date1995-03-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY is the device name listed in this FDA 510(k) record. The listed applicant is Calmed Technology, Inc.. It received FDA 510(k) clearance on 1995-03-21 under 510(k) number K950888. 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 SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY?

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is Calmed Technology, Inc.. The 510(k) number is K950888.

When did SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY receive FDA 510(k) clearance?

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY received FDA 510(k) clearance on 1995-03-21, under 510(k) number K950888.

Who is the listed applicant for SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY?

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

What is the FDA product code for SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY?

The FDA product code for SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY is EWO.

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Other records listing Calmed Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945689GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)K940999PRODIGIT 2000

Related Devices (Code: EWO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

Official Source

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