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FDA 510(k)

NOVAMETRIX MODEL 807 TRANSCUT. MONITOR

K-Number: K813350 · 1982-02-12

ApplicantNovametrix Medical Systems, Inc.
Decision Date1982-02-12
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NOVAMETRIX MODEL 807 TRANSCUT. MONITOR 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 1982-02-12 under 510(k) number K813350. 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 MODEL 807 TRANSCUT. MONITOR?

NOVAMETRIX MODEL 807 TRANSCUT. MONITOR is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K813350.

When did NOVAMETRIX MODEL 807 TRANSCUT. MONITOR receive FDA 510(k) clearance?

NOVAMETRIX MODEL 807 TRANSCUT. MONITOR received FDA 510(k) clearance on 1982-02-12, under 510(k) number K813350.

Who is the listed applicant for NOVAMETRIX MODEL 807 TRANSCUT. MONITOR?

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 MODEL 807 TRANSCUT. MONITOR?

The FDA product code for NOVAMETRIX MODEL 807 TRANSCUT. MONITOR is KLK.

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Other records listing Novametrix Medical Systems, Inc. as applicant

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Related Devices (Code: KLK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003943MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK991644MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK980287SIEMENS SC9000/SC9015 TCP02/C02 MODULESiemens Medical Solutions USA, Inc.K924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEAir-Shields, Inc.K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITORAir-Shields Vickers, Inc.K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEHewlett-Packard Co.

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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