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FDA 510(k)

PILOT TEST OR DETECTIVE AUDIOMETERS

K-Number: K060883 · 2006-06-23

ApplicantInteracoustics A/S
Decision Date2006-06-23
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PILOT TEST OR DETECTIVE AUDIOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K060883. 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 PILOT TEST OR DETECTIVE AUDIOMETERS?

PILOT TEST OR DETECTIVE AUDIOMETERS is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Interacoustics A/S. The 510(k) number is K060883.

When did PILOT TEST OR DETECTIVE AUDIOMETERS receive FDA 510(k) clearance?

PILOT TEST OR DETECTIVE AUDIOMETERS received FDA 510(k) clearance on 2006-06-23, under 510(k) number K060883.

Who is the listed applicant for PILOT TEST OR DETECTIVE AUDIOMETERS?

The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PILOT TEST OR DETECTIVE AUDIOMETERS?

The FDA product code for PILOT TEST OR DETECTIVE AUDIOMETERS is EWO.

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Other records listing Interacoustics A/S as applicant

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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.

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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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