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FDA 510(k)

NON-A-THERM

K-Number: K792037 · 1979-11-13

ApplicantLabarge, Inc.
Decision Date1979-11-13
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NON-A-THERM is the device name listed in this FDA 510(k) record. The listed applicant is Labarge, Inc.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K792037. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-A-THERM?

NON-A-THERM is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Labarge, Inc.. The 510(k) number is K792037.

When did NON-A-THERM receive FDA 510(k) clearance?

NON-A-THERM received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792037.

Who is the listed applicant for NON-A-THERM?

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

What is the FDA product code for NON-A-THERM?

The FDA product code for NON-A-THERM is KOD.

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.

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Other records listing Labarge, 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.

K771520ESOPHAGEAL STETHOSCOPEK771411ESOPHAGEAL STETH. TEMP. SENSORK760720MON-A-THERM TEMPARATURE MONITOR SYS

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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