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FDA 510(k)

HORIZON 2000 TRANSCUTANEOUS GAS MONITORING

K-Number: K860124 · 1986-05-09

ApplicantMennen Medical, Inc.
Decision Date1986-05-09
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HORIZON 2000 TRANSCUTANEOUS GAS MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical, Inc.. It received FDA 510(k) clearance on 1986-05-09 under 510(k) number K860124. 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 HORIZON 2000 TRANSCUTANEOUS GAS MONITORING?

HORIZON 2000 TRANSCUTANEOUS GAS MONITORING is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K860124.

When did HORIZON 2000 TRANSCUTANEOUS GAS MONITORING receive FDA 510(k) clearance?

HORIZON 2000 TRANSCUTANEOUS GAS MONITORING received FDA 510(k) clearance on 1986-05-09, under 510(k) number K860124.

Who is the listed applicant for HORIZON 2000 TRANSCUTANEOUS GAS MONITORING?

The FDA 510(k) record lists Mennen Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HORIZON 2000 TRANSCUTANEOUS GAS MONITORING?

The FDA product code for HORIZON 2000 TRANSCUTANEOUS GAS MONITORING is KLK.

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Other records listing Mennen Medical, Inc. 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.

K030722ENVOY PATIENT MONITORK983864ETCO2 VITAL SIGNS MODULEK991775MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WSK982697MODIFICATION TO ENSEMBLE CENTRAL STATION MONITORK974510ENVOY PATIENT MONITORK970358ENSEMBLE CENTRAL STATION MONITOR

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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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