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FDA 510(k)

VMI 1000 SURGICAL PACEOMETER

K-Number: K951145 · 1995-06-19

ApplicantVision Medical Instruments, Inc.
Decision Date1995-06-19
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VMI 1000 SURGICAL PACEOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Vision Medical Instruments, Inc.. It received FDA 510(k) clearance on 1995-06-19 under 510(k) number K951145. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VMI 1000 SURGICAL PACEOMETER?

VMI 1000 SURGICAL PACEOMETER is a medical device that received FDA 510(k) clearance on 1995-06-19. The listed applicant is Vision Medical Instruments, Inc.. The 510(k) number is K951145.

When did VMI 1000 SURGICAL PACEOMETER receive FDA 510(k) clearance?

VMI 1000 SURGICAL PACEOMETER received FDA 510(k) clearance on 1995-06-19, under 510(k) number K951145.

Who is the listed applicant for VMI 1000 SURGICAL PACEOMETER?

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

What is the FDA product code for VMI 1000 SURGICAL PACEOMETER?

The FDA product code for VMI 1000 SURGICAL PACEOMETER is ITX.

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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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