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FDA 510(k)

PRO-VIT

K-Number: K950799 · 1995-04-28

ApplicantM. Imonti and Associates Inc.,
Decision Date1995-04-28
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRO-VIT is the device name listed in this FDA 510(k) record. The listed applicant is M. Imonti and Associates Inc.,. It received FDA 510(k) clearance on 1995-04-28 under 510(k) number K950799. 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 PRO-VIT?

PRO-VIT is a medical device that received FDA 510(k) clearance on 1995-04-28. The listed applicant is M. Imonti and Associates Inc.,. The 510(k) number is K950799.

When did PRO-VIT receive FDA 510(k) clearance?

PRO-VIT received FDA 510(k) clearance on 1995-04-28, under 510(k) number K950799.

Who is the listed applicant for PRO-VIT?

The FDA 510(k) record lists M. Imonti and Associates Inc., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-VIT?

The FDA product code for PRO-VIT is HQE.

Other records listing M. Imonti and Associates 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.

K950800PRO-PAK FOR OMS DIPLOMATEK933627PHACOFRAGMENTOR TIPK933503PRO-PHACO HANDPIECEK924551ENDO TRACHEA TUBE FIXATIONK905766DRAINAGE TUBE RESTRAINT/WOUND COVER

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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