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FDA 510(k)

CRITIKON TRANSCUTANEOUS GAS MONITORS

K-Number: K813347 · 1982-01-26

ApplicantCritikon Company, LLC
Decision Date1982-01-26
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CRITIKON TRANSCUTANEOUS GAS MONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1982-01-26 under 510(k) number K813347. 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 CRITIKON TRANSCUTANEOUS GAS MONITORS?

CRITIKON TRANSCUTANEOUS GAS MONITORS is a medical device that received FDA 510(k) clearance on 1982-01-26. The listed applicant is Critikon Company, LLC. The 510(k) number is K813347.

When did CRITIKON TRANSCUTANEOUS GAS MONITORS receive FDA 510(k) clearance?

CRITIKON TRANSCUTANEOUS GAS MONITORS received FDA 510(k) clearance on 1982-01-26, under 510(k) number K813347.

Who is the listed applicant for CRITIKON TRANSCUTANEOUS GAS MONITORS?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRITIKON TRANSCUTANEOUS GAS MONITORS?

The FDA product code for CRITIKON TRANSCUTANEOUS GAS MONITORS is KLK.

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Other records listing Critikon Company, LLC as applicant

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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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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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