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FDA 510(k)

ARTICULATE FITTING SYSTEM

K-Number: K973320 · 1997-11-25

ApplicantDecibel Instruments, Inc.
Decision Date1997-11-25
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ARTICULATE FITTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Decibel Instruments, Inc.. It received FDA 510(k) clearance on 1997-11-25 under 510(k) number K973320. 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 ARTICULATE FITTING SYSTEM?

ARTICULATE FITTING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-25. The listed applicant is Decibel Instruments, Inc.. The 510(k) number is K973320.

When did ARTICULATE FITTING SYSTEM receive FDA 510(k) clearance?

ARTICULATE FITTING SYSTEM received FDA 510(k) clearance on 1997-11-25, under 510(k) number K973320.

Who is the listed applicant for ARTICULATE FITTING SYSTEM?

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

What is the FDA product code for ARTICULATE FITTING SYSTEM?

The FDA product code for ARTICULATE FITTING SYSTEM is EWO.

Related Clinical Trials

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Other records listing Decibel Instruments, 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.

K964603ARTICULAR HEARING AIDS

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

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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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