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FDA 510(k)

TELAMAT

K-Number: K864749 · 1987-02-10

ApplicantComet Ltd. C/O Radiology Resources, Inc.
Decision Date1987-02-10
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TELAMAT is the device name listed in this FDA 510(k) record. The listed applicant is Comet Ltd. C/O Radiology Resources, Inc.. It received FDA 510(k) clearance on 1987-02-10 under 510(k) number K864749. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELAMAT?

TELAMAT is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Comet Ltd. C/O Radiology Resources, Inc.. The 510(k) number is K864749.

When did TELAMAT receive FDA 510(k) clearance?

TELAMAT received FDA 510(k) clearance on 1987-02-10, under 510(k) number K864749.

Who is the listed applicant for TELAMAT?

The FDA 510(k) record lists Comet Ltd. C/O Radiology Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELAMAT?

The FDA product code for TELAMAT is JAA.

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 Comet Ltd. C/O Radiology Resources, 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.

K912338TUBE HOUSING ASSEMBLIESK911695VARIOUS X-RAY TUBESK910842DI2000/HS-45-150 X-RAY TUBE INSERTK901997X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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