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FDA 510(k)

360D DC DEFIBRILLATOR

K-Number: K874091 · 1987-11-23

ApplicantMedac, Inc.
Decision Date1987-11-23
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

360D DC DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medac, Inc.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K874091. 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 360D DC DEFIBRILLATOR?

360D DC DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Medac, Inc.. The 510(k) number is K874091.

When did 360D DC DEFIBRILLATOR receive FDA 510(k) clearance?

360D DC DEFIBRILLATOR received FDA 510(k) clearance on 1987-11-23, under 510(k) number K874091.

Who is the listed applicant for 360D DC DEFIBRILLATOR?

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

What is the FDA product code for 360D DC DEFIBRILLATOR?

The FDA product code for 360D DC DEFIBRILLATOR is LDD.

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Other records listing Medac, 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.

K874319MONITOR, ELECTROGRAPHICK874447DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELECK874090300M ECG MONITRO/TRANSCUTANEOUS PACEMAKERK871176PACE 10 NON-INVASIVE EXTERNAL PACEMAKERK864985DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCEK864988ETP 180E NON-INVASIVE EXTERNAL PACEMAKER

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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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