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FDA 510(k)

TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.

K-Number: K802846 · 1980-12-17

ApplicantThe London Co.
Decision Date1980-12-17
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. is the device name listed in this FDA 510(k) record. The listed applicant is The London Co.. It received FDA 510(k) clearance on 1980-12-17 under 510(k) number K802846. 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 TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.?

TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. is a medical device that received FDA 510(k) clearance on 1980-12-17. The listed applicant is The London Co.. The 510(k) number is K802846.

When did TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. receive FDA 510(k) clearance?

TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. received FDA 510(k) clearance on 1980-12-17, under 510(k) number K802846.

Who is the listed applicant for TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.?

The FDA 510(k) record lists The London Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.?

The FDA product code for TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. is KLK.

Other records listing The London Co. 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.

K801848ICA1 IONIZED CALCIUM ANALYZERK800224RADIOMETER ACID BASE LABORATORY-ABL-3K780652HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2K771444QUALICHECK TMK771263RADIOMHTER OSM-2 HEMOXIMETERK760229ACID BASE SYSTEM, RADIOMETER AUTOMATED

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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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