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FDA 510(k)

SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)

K-Number: K883603 · 1988-11-03

Applicant3M Health Care, Sarns
Decision Date1988-11-03
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Sarns. It received FDA 510(k) clearance on 1988-11-03 under 510(k) number K883603. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)?

SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) is a medical device that received FDA 510(k) clearance on 1988-11-03. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K883603.

When did SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) receive FDA 510(k) clearance?

SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) received FDA 510(k) clearance on 1988-11-03, under 510(k) number K883603.

Who is the listed applicant for SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)?

The FDA 510(k) record lists 3M Health Care, Sarns as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)?

The FDA product code for SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) is DWC.

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Other records listing 3M Health Care, Sarns 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.

K960916SAMS 8000 CARDIOPLEGIA MONITORK953901SARNS 800 ROLLER PUMPK9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEMK941653SARNS TURBO MEMBRANE OXYGENATOR MODIFICATIONK941654SARNS FILTERED VENOUS RESERVIOR MODIFICATIONK940651SARNS ULTRASONIC AIR SENSOR

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Related Devices (Code: DWC)

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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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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