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FDA 510(k)

ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204

K-Number: K092111 · 2009-10-02

ApplicantEntomed AB
Decision Date2009-10-02
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 is the device name listed in this FDA 510(k) record. The listed applicant is Entomed AB. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K092111. 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 ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is Entomed AB. The 510(k) number is K092111.

When did ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 receive FDA 510(k) clearance?

ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 received FDA 510(k) clearance on 2009-10-02, under 510(k) number K092111.

Who is the listed applicant for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

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

What is the FDA product code for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

The FDA product code for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 is EWO.

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Related Devices (Code: EWO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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