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FDA 510(k)

HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR

K-Number: K905393 · 1991-01-16

ApplicantFrigitronics, Inc.
Decision Date1991-01-16
Product CodeFWF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Frigitronics, Inc.. It received FDA 510(k) clearance on 1991-01-16 under 510(k) number K905393. The device is classified under product code FWF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR?

HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR is a medical device that received FDA 510(k) clearance on 1991-01-16. The listed applicant is Frigitronics, Inc.. The 510(k) number is K905393.

When did HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR receive FDA 510(k) clearance?

HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR received FDA 510(k) clearance on 1991-01-16, under 510(k) number K905393.

Who is the listed applicant for HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR?

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

What is the FDA product code for HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR?

The FDA product code for HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR is FWF.

Related Clinical Trials

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Other records listing Frigitronics, 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.

K905392HT4-SERIES HYSTEROSCOPES AND ACCESSORIESK905495HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR

Related Devices (Code: FWF)

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.

K053412FLEXISCOPE, MODELS 50MH AND 50 MHCSchoelly Imaging, Inc.K990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMKarl Storz Imaging, Inc.K982754EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs ConsultingK982965ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIESRichard Wolf Medical Instruments Corp.K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMAngiolaz, Inc.K982409VES 1501-MAngiolaz, Inc.

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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