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FDA 510(k)

KERMATH THERAPY SIMULATOR

K-Number: K812726 · 1981-11-05

ApplicantKermath Mfg. Corp.
Decision Date1981-11-05
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KERMATH THERAPY SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kermath Mfg. Corp.. It received FDA 510(k) clearance on 1981-11-05 under 510(k) number K812726. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERMATH THERAPY SIMULATOR?

KERMATH THERAPY SIMULATOR is a medical device that received FDA 510(k) clearance on 1981-11-05. The listed applicant is Kermath Mfg. Corp.. The 510(k) number is K812726.

When did KERMATH THERAPY SIMULATOR receive FDA 510(k) clearance?

KERMATH THERAPY SIMULATOR received FDA 510(k) clearance on 1981-11-05, under 510(k) number K812726.

Who is the listed applicant for KERMATH THERAPY SIMULATOR?

The FDA 510(k) record lists Kermath Mfg. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KERMATH THERAPY SIMULATOR?

The FDA product code for KERMATH THERAPY SIMULATOR is KPQ.

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 Kermath Mfg. Corp. 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.

K870221T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)K812332KERMATH L/C ARMK811215KERMATH RADIOGRAPHIC HEAD STANDK771549VERSATOME

Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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