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FDA 510(k)

I/A - VFE SYSTEM II

K-Number: K854868 · 1986-02-07

ApplicantMira, Inc.
Decision Date1986-02-07
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

I/A - VFE SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Mira, Inc.. It received FDA 510(k) clearance on 1986-02-07 under 510(k) number K854868. 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 I/A - VFE SYSTEM II?

I/A - VFE SYSTEM II is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is Mira, Inc.. The 510(k) number is K854868.

When did I/A - VFE SYSTEM II receive FDA 510(k) clearance?

I/A - VFE SYSTEM II received FDA 510(k) clearance on 1986-02-07, under 510(k) number K854868.

Who is the listed applicant for I/A - VFE SYSTEM II?

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

What is the FDA product code for I/A - VFE SYSTEM II?

The FDA product code for I/A - VFE SYSTEM II is HQE.

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Other records listing Mira, Inc. as applicant

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Related Devices (Code: HQE)

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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

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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