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FDA 510(k)

KERMATH L/C ARM

K-Number: K812332 · 1981-09-16

ApplicantKermath Mfg. Corp.
Decision Date1981-09-16
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KERMATH L/C ARM 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 1981-09-16 under 510(k) number K812332. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERMATH L/C ARM?

KERMATH L/C ARM is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Kermath Mfg. Corp.. The 510(k) number is K812332.

When did KERMATH L/C ARM receive FDA 510(k) clearance?

KERMATH L/C ARM received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812332.

Who is the listed applicant for KERMATH L/C ARM?

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 L/C ARM?

The FDA product code for KERMATH L/C ARM is KPR.

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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)K812726KERMATH THERAPY SIMULATORK811215KERMATH RADIOGRAPHIC HEAD STANDK771549VERSATOME

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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