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FDA 510(k)

NOVAMETRIX PULSE OXIMETER, MODEL 500

K-Number: K853124 · 1985-11-06

ApplicantNovametrix Medical Systems, Inc.
Decision Date1985-11-06
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVAMETRIX PULSE OXIMETER, MODEL 500 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 1985-11-06 under 510(k) number K853124. 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 NOVAMETRIX PULSE OXIMETER, MODEL 500?

NOVAMETRIX PULSE OXIMETER, MODEL 500 is a medical device that received FDA 510(k) clearance on 1985-11-06. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K853124.

When did NOVAMETRIX PULSE OXIMETER, MODEL 500 receive FDA 510(k) clearance?

NOVAMETRIX PULSE OXIMETER, MODEL 500 received FDA 510(k) clearance on 1985-11-06, under 510(k) number K853124.

Who is the listed applicant for NOVAMETRIX PULSE OXIMETER, MODEL 500?

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 NOVAMETRIX PULSE OXIMETER, MODEL 500?

The FDA product code for NOVAMETRIX PULSE OXIMETER, MODEL 500 is JOM.

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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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