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FDA 510(k)

NORMATEC PCD

K-Number: K013436 · 2001-12-21

ApplicantNormatec, Inc.
Decision Date2001-12-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NORMATEC PCD is the device name listed in this FDA 510(k) record. The listed applicant is Normatec, Inc.. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K013436. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMATEC PCD?

NORMATEC PCD is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Normatec, Inc.. The 510(k) number is K013436.

When did NORMATEC PCD receive FDA 510(k) clearance?

NORMATEC PCD received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013436.

Who is the listed applicant for NORMATEC PCD?

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

What is the FDA product code for NORMATEC PCD?

The FDA product code for NORMATEC PCD is JOW.

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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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