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FDA 510(k)

ISOLATED CAMERA HEAD

K-Number: K944707 · 1994-10-07

ApplicantEnvision Medical Corp.
Decision Date1994-10-07
Product CodeFWF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLATED CAMERA HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Envision Medical Corp.. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K944707. 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 ISOLATED CAMERA HEAD?

ISOLATED CAMERA HEAD is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Envision Medical Corp.. The 510(k) number is K944707.

When did ISOLATED CAMERA HEAD receive FDA 510(k) clearance?

ISOLATED CAMERA HEAD received FDA 510(k) clearance on 1994-10-07, under 510(k) number K944707.

Who is the listed applicant for ISOLATED CAMERA HEAD?

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

What is the FDA product code for ISOLATED CAMERA HEAD?

The FDA product code for ISOLATED CAMERA HEAD is FWF.

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 Envision Medical 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.

K9706053-CCD DIGITAL CAMERAK953438SURGICAL INTEGRATED CAMERA SYSTEMK951971XENON LIGHT SOURCEK934092CAMERA, SURGICAL AND ACCESSORIES

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

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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