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FDA 510(k)

DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.

K-Number: K894355 · 1989-12-12

ApplicantPhycon
Decision Date1989-12-12
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. is the device name listed in this FDA 510(k) record. The listed applicant is Phycon. It received FDA 510(k) clearance on 1989-12-12 under 510(k) number K894355. 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 DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.?

DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Phycon. The 510(k) number is K894355.

When did DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. receive FDA 510(k) clearance?

DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. received FDA 510(k) clearance on 1989-12-12, under 510(k) number K894355.

Who is the listed applicant for DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.?

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

What is the FDA product code for DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.?

The FDA product code for DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. 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 Phycon 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.

K894356DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.

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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