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FDA 510(k)

MICROGAS 7650 TRANSCUTANEOUS MONITOR

K-Number: K003943 · 2001-05-04

ApplicantLinde Medical Sensors AG
Decision Date2001-05-04
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROGAS 7650 TRANSCUTANEOUS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Linde Medical Sensors AG. It received FDA 510(k) clearance on 2001-05-04 under 510(k) number K003943. 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 MICROGAS 7650 TRANSCUTANEOUS MONITOR?

MICROGAS 7650 TRANSCUTANEOUS MONITOR is a medical device that received FDA 510(k) clearance on 2001-05-04. The listed applicant is Linde Medical Sensors AG. The 510(k) number is K003943.

When did MICROGAS 7650 TRANSCUTANEOUS MONITOR receive FDA 510(k) clearance?

MICROGAS 7650 TRANSCUTANEOUS MONITOR received FDA 510(k) clearance on 2001-05-04, under 510(k) number K003943.

Who is the listed applicant for MICROGAS 7650 TRANSCUTANEOUS MONITOR?

The FDA 510(k) record lists Linde Medical Sensors AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROGAS 7650 TRANSCUTANEOUS MONITOR?

The FDA product code for MICROGAS 7650 TRANSCUTANEOUS MONITOR is KLK.

Related Clinical Trials

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.

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Other records listing Linde Medical Sensors AG 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.

K043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009K032291TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEMK991644MICROGAS 7650 TRANSCUTANEOUS MONITOR

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.

K991644MICROGAS 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.K893133HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXXMennen Medical, Inc.

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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