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FDA 510(k)

TRUEHD (1080P) DIGITAL CAMERA SYSTEM

K-Number: K063457 · 2006-12-05

ApplicantConmed Linvatec
Decision Date2006-12-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRUEHD (1080P) DIGITAL CAMERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Linvatec. It received FDA 510(k) clearance on 2006-12-05 under 510(k) number K063457. 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 TRUEHD (1080P) DIGITAL CAMERA SYSTEM?

TRUEHD (1080P) DIGITAL CAMERA SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Conmed Linvatec. The 510(k) number is K063457.

When did TRUEHD (1080P) DIGITAL CAMERA SYSTEM receive FDA 510(k) clearance?

TRUEHD (1080P) DIGITAL CAMERA SYSTEM received FDA 510(k) clearance on 2006-12-05, under 510(k) number K063457.

Who is the listed applicant for TRUEHD (1080P) DIGITAL CAMERA SYSTEM?

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

What is the FDA product code for TRUEHD (1080P) DIGITAL CAMERA SYSTEM?

The FDA product code for TRUEHD (1080P) DIGITAL CAMERA SYSTEM is GCJ.

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Other records listing Conmed Linvatec 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.

K111779Y-KNOT ALL-SUTURE ANCHOR MODEL HF13K102410MATRYX INTERFERENCE SCREW (5.0-6.5MM)K102339CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICEK101100CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503K092898CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURESK090560CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS

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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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