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FDA 510(k)

CLEM TM

K-Number: K902788 · 1990-09-12

ApplicantArbo Medical, Inc.
Decision Date1990-09-12
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLEM TM is the device name listed in this FDA 510(k) record. The listed applicant is Arbo Medical, Inc.. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K902788. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEM TM?

CLEM TM is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Arbo Medical, Inc.. The 510(k) number is K902788.

When did CLEM TM receive FDA 510(k) clearance?

CLEM TM received FDA 510(k) clearance on 1990-09-12, under 510(k) number K902788.

Who is the listed applicant for CLEM TM?

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

What is the FDA product code for CLEM TM?

The FDA product code for CLEM TM is FIB.

Other records listing Arbo 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.

K940323ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEMK935437ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODESK942905DISPOSABLE TEMPERATURE PROBE COVERK940302ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEMK940322ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIREK935246ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES

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Related Devices (Code: FIB)

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.

K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical CorporationK001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2Fresenius Medical Care North America

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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