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FDA 510(k)

PNEUMATHERM

K-Number: K922089 · 1993-02-23

Decision Date1993-02-23
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PNEUMATHERM is the device name listed in this FDA 510(k) record. The listed applicant is National Pain Institute. It received FDA 510(k) clearance on 1993-02-23 under 510(k) number K922089. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMATHERM?

PNEUMATHERM is a medical device that received FDA 510(k) clearance on 1993-02-23. The listed applicant is National Pain Institute. The 510(k) number is K922089.

When did PNEUMATHERM receive FDA 510(k) clearance?

PNEUMATHERM received FDA 510(k) clearance on 1993-02-23, under 510(k) number K922089.

Who is the listed applicant for PNEUMATHERM?

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

What is the FDA product code for PNEUMATHERM?

The FDA product code for PNEUMATHERM is IRT.

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.

Related Devices (Code: IRT)

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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