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FDA 510(k)

PACEMAKER PULSE GENERATOR W/ELECTRODE

K-Number: K840353 · 1984-04-23

ApplicantRoss Research, Inc.
Decision Date1984-04-23
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMAKER PULSE GENERATOR W/ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ross Research, Inc.. It received FDA 510(k) clearance on 1984-04-23 under 510(k) number K840353. 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 PACEMAKER PULSE GENERATOR W/ELECTRODE?

PACEMAKER PULSE GENERATOR W/ELECTRODE is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Ross Research, Inc.. The 510(k) number is K840353.

When did PACEMAKER PULSE GENERATOR W/ELECTRODE receive FDA 510(k) clearance?

PACEMAKER PULSE GENERATOR W/ELECTRODE received FDA 510(k) clearance on 1984-04-23, under 510(k) number K840353.

Who is the listed applicant for PACEMAKER PULSE GENERATOR W/ELECTRODE?

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

What is the FDA product code for PACEMAKER PULSE GENERATOR W/ELECTRODE?

The FDA product code for PACEMAKER PULSE GENERATOR W/ELECTRODE is DRO.

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.

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Other records listing Ross Research, 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.

K822246NONINVASIVE TEMPORARY PACEMAKER

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT 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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