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FDA 510(k)

NOVATEC PRM

K-Number: K790450 · 1979-04-06

ApplicantNovatec, Inc.
Decision Date1979-04-06
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVATEC PRM is the device name listed in this FDA 510(k) record. The listed applicant is Novatec, Inc.. It received FDA 510(k) clearance on 1979-04-06 under 510(k) number K790450. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATEC PRM?

NOVATEC PRM is a medical device that received FDA 510(k) clearance on 1979-04-06. The listed applicant is Novatec, Inc.. The 510(k) number is K790450.

When did NOVATEC PRM receive FDA 510(k) clearance?

NOVATEC PRM received FDA 510(k) clearance on 1979-04-06, under 510(k) number K790450.

Who is the listed applicant for NOVATEC PRM?

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

What is the FDA product code for NOVATEC PRM?

The FDA product code for NOVATEC PRM is JOM.

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.

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Other records listing Novatec, Inc. 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.

K820242DIGICUFF

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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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