FDA 510(k)

NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER

K-Number: K893643 · 1989-10-26

ApplicantNovametrix Medical Systems, Inc.

Decision Date1989-10-26

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER 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 1989-10-26 under 510(k) number K893643. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER?

NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER is a medical device that received FDA 510(k) clearance on 1989-10-26. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K893643.

When did NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER receive FDA 510(k) clearance?

NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER received FDA 510(k) clearance on 1989-10-26, under 510(k) number K893643.

Who is the listed applicant for NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER?

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 MDLS 500A, 505A, 515A, & 7000A OXIMETER?

The FDA product code for NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER is DQA.

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Other records listing Novametrix Medical Systems, Inc. as applicant

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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.