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FDA 510(k)

MODEL #210 STEALTH DEFIB PADS

K-Number: K904462 · 1990-12-03

ApplicantCardiotronics, Inc.
Decision Date1990-12-03
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL #210 STEALTH DEFIB PADS is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1990-12-03 under 510(k) number K904462. 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 MODEL #210 STEALTH DEFIB PADS?

MODEL #210 STEALTH DEFIB PADS is a medical device that received FDA 510(k) clearance on 1990-12-03. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K904462.

When did MODEL #210 STEALTH DEFIB PADS receive FDA 510(k) clearance?

MODEL #210 STEALTH DEFIB PADS received FDA 510(k) clearance on 1990-12-03, under 510(k) number K904462.

Who is the listed applicant for MODEL #210 STEALTH DEFIB PADS?

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

What is the FDA product code for MODEL #210 STEALTH DEFIB PADS?

The FDA product code for MODEL #210 STEALTH DEFIB PADS is LDD.

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Other records listing Cardiotronics, 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.

K932903EKG VESTK922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODEK923297MODEL #340 STEALTH-TRODE+LSK922227MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILEK922172MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)K922173MODEL # 830 ST ADULT STIMULATION PADS (STERILE)

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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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