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FDA 510(k)

TMO INTEGRATED CIRCUIT SYSTEM

K-Number: K820406 · 1982-03-02

ApplicantTravenol Laboratories, S.A.
Decision Date1982-03-02
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TMO INTEGRATED CIRCUIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1982-03-02 under 510(k) number K820406. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMO INTEGRATED CIRCUIT SYSTEM?

TMO INTEGRATED CIRCUIT SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K820406.

When did TMO INTEGRATED CIRCUIT SYSTEM receive FDA 510(k) clearance?

TMO INTEGRATED CIRCUIT SYSTEM received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820406.

Who is the listed applicant for TMO INTEGRATED CIRCUIT SYSTEM?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TMO INTEGRATED CIRCUIT SYSTEM?

The FDA product code for TMO INTEGRATED CIRCUIT SYSTEM is KRI.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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Related Devices (Code: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia Medical Products, Inc.

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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