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FDA 510(k)

NOVATRACER RECORDER

K-Number: K811453 · 1981-07-10

ApplicantNovametrix Medical Systems, Inc.
Decision Date1981-07-10
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVATRACER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Novametrix Medical Systems, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811453. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATRACER RECORDER?

NOVATRACER RECORDER is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K811453.

When did NOVATRACER RECORDER receive FDA 510(k) clearance?

NOVATRACER RECORDER received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811453.

Who is the listed applicant for NOVATRACER RECORDER?

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

What is the FDA product code for NOVATRACER RECORDER?

The FDA product code for NOVATRACER RECORDER is DSF.

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Other records listing Novametrix Medical Systems, Inc. as applicant

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Related Devices (Code: DSF)

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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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