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FDA 510(k)

NORMATEC MVP

K-Number: K112890 · 2012-01-04

Decision Date2012-01-04
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NORMATEC MVP is the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2012-01-04 under 510(k) number K112890. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMATEC MVP?

NORMATEC MVP is a medical device that received FDA 510(k) clearance on 2012-01-04. The listed applicant is NormaTec Industries, LP. The 510(k) number is K112890.

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

NORMATEC MVP received FDA 510(k) clearance on 2012-01-04, under 510(k) number K112890.

Who is the listed applicant for NORMATEC MVP?

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

What is the FDA product code for NORMATEC MVP?

The FDA product code for NORMATEC MVP is IRP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing NormaTec Industries, LP as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 9 devices →

Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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