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FDA 510(k)

NONINVASIVE TEMPORARY PACEMAKER

K-Number: K822246 · 1982-08-06

ApplicantRoss Research, Inc.
Decision Date1982-08-06
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NONINVASIVE TEMPORARY PACEMAKER 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 1982-08-06 under 510(k) number K822246. 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 NONINVASIVE TEMPORARY PACEMAKER?

NONINVASIVE TEMPORARY PACEMAKER is a medical device that received FDA 510(k) clearance on 1982-08-06. The listed applicant is Ross Research, Inc.. The 510(k) number is K822246.

When did NONINVASIVE TEMPORARY PACEMAKER receive FDA 510(k) clearance?

NONINVASIVE TEMPORARY PACEMAKER received FDA 510(k) clearance on 1982-08-06, under 510(k) number K822246.

Who is the listed applicant for NONINVASIVE TEMPORARY PACEMAKER?

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 NONINVASIVE TEMPORARY PACEMAKER?

The FDA product code for NONINVASIVE TEMPORARY PACEMAKER is DRO.

Related Clinical Trials

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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.

K840353PACEMAKER PULSE GENERATOR W/ELECTRODE

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 ElectronicsK983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, 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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