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FDA 510(k)

SARNS AIR DETECTION SYSTEM

K-Number: K935977 · 1994-02-04

Applicant3M Health Care, Sarns
Decision Date1994-02-04
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS AIR DETECTION SYSTEM 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 1994-02-04 under 510(k) number K935977. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS AIR DETECTION SYSTEM?

SARNS AIR DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K935977.

When did SARNS AIR DETECTION SYSTEM receive FDA 510(k) clearance?

SARNS AIR DETECTION SYSTEM received FDA 510(k) clearance on 1994-02-04, under 510(k) number K935977.

Who is the listed applicant for SARNS AIR DETECTION SYSTEM?

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 AIR DETECTION SYSTEM?

The FDA product code for SARNS AIR DETECTION SYSTEM is KRL.

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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: KRL)

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.

K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbHK090698CAPIOX BUBBLE TRAP WITH X-COATINGTerumo Cardiovascular SystemsK071231EDAC QUANTIFIERLuna Innovations, Inc.K961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, Sarns

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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