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FDA 510(k)

CARDIOPAC DEFIBRILLATOR 444

K-Number: K844103 · 1985-01-18

ApplicantBirtcher Corp.
Decision Date1985-01-18
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPAC DEFIBRILLATOR 444 is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K844103. 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 CARDIOPAC DEFIBRILLATOR 444?

CARDIOPAC DEFIBRILLATOR 444 is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Birtcher Corp.. The 510(k) number is K844103.

When did CARDIOPAC DEFIBRILLATOR 444 receive FDA 510(k) clearance?

CARDIOPAC DEFIBRILLATOR 444 received FDA 510(k) clearance on 1985-01-18, under 510(k) number K844103.

Who is the listed applicant for CARDIOPAC DEFIBRILLATOR 444?

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

What is the FDA product code for CARDIOPAC DEFIBRILLATOR 444?

The FDA product code for CARDIOPAC DEFIBRILLATOR 444 is LDD.

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Other records listing Birtcher Corp. 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.

K881328MODEL 375 ECGK860687BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768K860718ELECTROSURGERY PENCIL, MODEL 767K854814SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33K854864BI-POLAR FORCEPSK850943MODEL 775 BIPOLAR COAGULATOR

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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

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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