Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THERMODYN

K-Number: K923396 · 1993-05-26

Decision Date1993-05-26
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMODYN is the device name listed in this FDA 510(k) record. The listed applicant is Nemectron Medical, Inc.. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K923396. 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 THERMODYN?

THERMODYN is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Nemectron Medical, Inc.. The 510(k) number is K923396.

When did THERMODYN receive FDA 510(k) clearance?

THERMODYN received FDA 510(k) clearance on 1993-05-26, under 510(k) number K923396.

Who is the listed applicant for THERMODYN?

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

What is the FDA product code for THERMODYN?

The FDA product code for THERMODYN 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.

Other records listing Nemectron Medical, 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.

View all 13 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑