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FDA 510(k)

VASOGENICS EECP-MC2

K-Number: K940264 · 1995-02-23

ApplicantVasogenics, Inc.
Decision Date1995-02-23
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASOGENICS EECP-MC2 is the device name listed in this FDA 510(k) record. The listed applicant is Vasogenics, Inc.. It received FDA 510(k) clearance on 1995-02-23 under 510(k) number K940264. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASOGENICS EECP-MC2?

VASOGENICS EECP-MC2 is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Vasogenics, Inc.. The 510(k) number is K940264.

When did VASOGENICS EECP-MC2 receive FDA 510(k) clearance?

VASOGENICS EECP-MC2 received FDA 510(k) clearance on 1995-02-23, under 510(k) number K940264.

Who is the listed applicant for VASOGENICS EECP-MC2?

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

What is the FDA product code for VASOGENICS EECP-MC2?

The FDA product code for VASOGENICS EECP-MC2 is DRN.

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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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