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FDA 510(k)

VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE

K-Number: K991303 · 1999-07-12

ApplicantVista Medical Technologies, Inc.
Decision Date1999-07-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Vista Medical Technologies, Inc.. It received FDA 510(k) clearance on 1999-07-12 under 510(k) number K991303. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE?

VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE is a medical device that received FDA 510(k) clearance on 1999-07-12. The listed applicant is Vista Medical Technologies, Inc.. The 510(k) number is K991303.

When did VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE receive FDA 510(k) clearance?

VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE received FDA 510(k) clearance on 1999-07-12, under 510(k) number K991303.

Who is the listed applicant for VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE?

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

What is the FDA product code for VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE?

The FDA product code for VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE is GCJ.

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Other records listing Vista Medical Technologies, 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.

K021290VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100K020301MODIFICATION TO VISTA STEREOSCOPE SYSTEMK990635VISTA STEREOSCOPE SYSTEMK973436VISTA HEAD MOUNTED DISPLAYK971373VISTA SINGLE CHIP VIDEO CAMERAK970217VISTA ILLUMINATION SYSTEM

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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