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FDA 510(k)

NEONATAL PHYSIOLOGICAL MONITOR 903

K-Number: K840560 · 1984-04-17

ApplicantNovametrix Medical Systems, Inc.
Decision Date1984-04-17
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEONATAL PHYSIOLOGICAL MONITOR 903 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 1984-04-17 under 510(k) number K840560. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL PHYSIOLOGICAL MONITOR 903?

NEONATAL PHYSIOLOGICAL MONITOR 903 is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K840560.

When did NEONATAL PHYSIOLOGICAL MONITOR 903 receive FDA 510(k) clearance?

NEONATAL PHYSIOLOGICAL MONITOR 903 received FDA 510(k) clearance on 1984-04-17, under 510(k) number K840560.

Who is the listed applicant for NEONATAL PHYSIOLOGICAL MONITOR 903?

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 NEONATAL PHYSIOLOGICAL MONITOR 903?

The FDA product code for NEONATAL PHYSIOLOGICAL MONITOR 903 is DRT.

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Related Devices (Code: DRT)

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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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