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FDA 510(k)

VIDEO CAMERA SYSTEM

K-Number: K863598 · 1986-10-02

ApplicantAmerican Edwards Laboratories
Decision Date1986-10-02
Product CodeFWF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIDEO CAMERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1986-10-02 under 510(k) number K863598. 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 VIDEO CAMERA SYSTEM?

VIDEO CAMERA SYSTEM is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is American Edwards Laboratories. The 510(k) number is K863598.

When did VIDEO CAMERA SYSTEM receive FDA 510(k) clearance?

VIDEO CAMERA SYSTEM received FDA 510(k) clearance on 1986-10-02, under 510(k) number K863598.

Who is the listed applicant for VIDEO CAMERA SYSTEM?

The FDA 510(k) record lists American Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIDEO CAMERA SYSTEM?

The FDA product code for VIDEO CAMERA SYSTEM is FWF.

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Other records listing American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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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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