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FDA 510(k)

FORTE ES-400

K-Number: K953615 · 1995-10-27

Decision Date1995-10-27
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

FORTE ES-400 is the device name listed in this FDA 510(k) record. The listed applicant is Chattanooga Group, Inc.. It received FDA 510(k) clearance on 1995-10-27 under 510(k) number K953615. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FORTE ES-400?

FORTE ES-400 is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Chattanooga Group, Inc.. The 510(k) number is K953615.

When did FORTE ES-400 receive FDA 510(k) clearance?

FORTE ES-400 received FDA 510(k) clearance on 1995-10-27, under 510(k) number K953615.

Who is the listed applicant for FORTE ES-400?

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

What is the FDA product code for FORTE ES-400?

The FDA product code for FORTE ES-400 is IPF.

Related Clinical Trials

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.

Other records listing Chattanooga Group, 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.

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Related Devices (Code: IPF)

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.

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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