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FDA 510(k)

DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.

K-Number: K894356 · 1989-12-13

ApplicantPhycon
Decision Date1989-12-13
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. is the device name listed in this FDA 510(k) record. The listed applicant is Phycon. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K894356. 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. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.?

DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Phycon. The 510(k) number is K894356.

When did DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. receive FDA 510(k) clearance?

DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. received FDA 510(k) clearance on 1989-12-13, under 510(k) number K894356.

Who is the listed applicant for DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.?

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. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.?

The FDA product code for DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. 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.

K894355DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.

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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