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FDA 510(k)

VIT COMMANDER SYSTEM

K-Number: K961738 · 1996-11-25

ApplicantScieran Technologies, Inc.
Decision Date1996-11-25
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VIT COMMANDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scieran Technologies, Inc.. It received FDA 510(k) clearance on 1996-11-25 under 510(k) number K961738. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIT COMMANDER SYSTEM?

VIT COMMANDER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Scieran Technologies, Inc.. The 510(k) number is K961738.

When did VIT COMMANDER SYSTEM receive FDA 510(k) clearance?

VIT COMMANDER SYSTEM received FDA 510(k) clearance on 1996-11-25, under 510(k) number K961738.

Who is the listed applicant for VIT COMMANDER SYSTEM?

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

What is the FDA product code for VIT COMMANDER SYSTEM?

The FDA product code for VIT COMMANDER SYSTEM is HQE.

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 Scieran 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.

K974253CPD COMMANDERK980085PHACO COMMANDERK973749FRAG COMMANDERK960767LIGHT COMMANDER

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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