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FDA 510(k)

INTEGRATED VISUALIZATION SYSTEM

K-Number: K925108 · 1993-01-29

ApplicantNeuro Navigational Corp.
Decision Date1993-01-29
Product CodeFWF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTEGRATED VISUALIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Navigational Corp.. It received FDA 510(k) clearance on 1993-01-29 under 510(k) number K925108. 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 INTEGRATED VISUALIZATION SYSTEM?

INTEGRATED VISUALIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-01-29. The listed applicant is Neuro Navigational Corp.. The 510(k) number is K925108.

When did INTEGRATED VISUALIZATION SYSTEM receive FDA 510(k) clearance?

INTEGRATED VISUALIZATION SYSTEM received FDA 510(k) clearance on 1993-01-29, under 510(k) number K925108.

Who is the listed applicant for INTEGRATED VISUALIZATION SYSTEM?

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

What is the FDA product code for INTEGRATED VISUALIZATION SYSTEM?

The FDA product code for INTEGRATED VISUALIZATION SYSTEM is FWF.

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Other records listing Neuro Navigational 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.

K9650782.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPSK961406NEUROVIEW SCISSORSK9611731.2MM REUSABLE NEUROVIEW ENDOSCOPEK961300ASPIRATION/IRRIGATION CATHETERK960792DISPOSABLE NEUROVIEW INTRODUCER SHEATHK954938DISPOSABLE NEUROVIEW OPERATING SHEATH

View all 23 devices →

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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