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FDA 510(k)

NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2

K-Number: K844253 · 1985-01-10

ApplicantNovametrix Medical Systems, Inc.
Decision Date1985-01-10
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 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 1985-01-10 under 510(k) number K844253. The device is classified under product code KLK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2?

NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 is a medical device that received FDA 510(k) clearance on 1985-01-10. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K844253.

When did NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 receive FDA 510(k) clearance?

NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 received FDA 510(k) clearance on 1985-01-10, under 510(k) number K844253.

Who is the listed applicant for NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2?

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 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2?

The FDA product code for NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 is KLK.

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Related Devices (Code: KLK)

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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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