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FDA 510(k)

MODEL 205 SHOCK-TRODE

K-Number: K910661 · 1991-05-02

ApplicantCardiotronics, Inc.
Decision Date1991-05-02
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 205 SHOCK-TRODE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1991-05-02 under 510(k) number K910661. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 205 SHOCK-TRODE?

MODEL 205 SHOCK-TRODE is a medical device that received FDA 510(k) clearance on 1991-05-02. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K910661.

When did MODEL 205 SHOCK-TRODE receive FDA 510(k) clearance?

MODEL 205 SHOCK-TRODE received FDA 510(k) clearance on 1991-05-02, under 510(k) number K910661.

Who is the listed applicant for MODEL 205 SHOCK-TRODE?

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 205 SHOCK-TRODE?

The FDA product code for MODEL 205 SHOCK-TRODE is DRO.

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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: DRO)

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.

K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, 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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