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FDA 510(k)

MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS

K-Number: K092244 · 2010-03-01

ApplicantDiagnostic Group, LLC
Decision Date2010-03-01
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Group, LLC. It received FDA 510(k) clearance on 2010-03-01 under 510(k) number K092244. 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 MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS?

MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Diagnostic Group, LLC. The 510(k) number is K092244.

When did MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS receive FDA 510(k) clearance?

MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS received FDA 510(k) clearance on 2010-03-01, under 510(k) number K092244.

Who is the listed applicant for MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS?

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

What is the FDA product code for MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS?

The FDA product code for MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS 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.

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