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FDA 510(k)

VCARE A

K-Number: K121817 · 2013-09-17

ApplicantIVT Medical, Ltd.
Decision Date2013-09-17
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VCARE A is the device name listed in this FDA 510(k) record. The listed applicant is IVT Medical, Ltd.. It received FDA 510(k) clearance on 2013-09-17 under 510(k) number K121817. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VCARE A?

VCARE A is a medical device that received FDA 510(k) clearance on 2013-09-17. The listed applicant is IVT Medical, Ltd.. The 510(k) number is K121817.

When did VCARE A receive FDA 510(k) clearance?

VCARE A received FDA 510(k) clearance on 2013-09-17, under 510(k) number K121817.

Who is the listed applicant for VCARE A?

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

What is the FDA product code for VCARE A?

The FDA product code for VCARE A is OMP.

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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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