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FDA 510(k)

LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)

K-Number: K922563 · 1992-07-28

ApplicantRaco Products Co.
Decision Date1992-07-28
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Raco Products Co.. It received FDA 510(k) clearance on 1992-07-28 under 510(k) number K922563. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)?

LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Raco Products Co.. The 510(k) number is K922563.

When did LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) receive FDA 510(k) clearance?

LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) received FDA 510(k) clearance on 1992-07-28, under 510(k) number K922563.

Who is the listed applicant for LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)?

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

What is the FDA product code for LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)?

The FDA product code for LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) is LDD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Raco Products 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.

K932046LIFE-TELL T.S.S.K923493LIFE-TEL T.R.S.K920990LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)

Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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