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FDA 510(k)

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER

K-Number: K903437 · 1990-11-16

ApplicantKeller Medical Specialties Products, Inc.
Decision Date1990-11-16
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER is the device name listed in this FDA 510(k) record. The listed applicant is Keller Medical Specialties Products, Inc.. It received FDA 510(k) clearance on 1990-11-16 under 510(k) number K903437. 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 DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER?

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER is a medical device that received FDA 510(k) clearance on 1990-11-16. The listed applicant is Keller Medical Specialties Products, Inc.. The 510(k) number is K903437.

When did DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER receive FDA 510(k) clearance?

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER received FDA 510(k) clearance on 1990-11-16, under 510(k) number K903437.

Who is the listed applicant for DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER?

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

What is the FDA product code for DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER?

The FDA product code for DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER 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 Keller Medical Specialties Products, 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.

K990648KELLER VITAL SIGNS MONITOR, KMS 890+K982331KELLER PULSE OXIMETER, MODEL 850+K914576KELLER CARDIAC MONITOR MEDIL KMS870K910262KELLER VITAL SIGNS MONITOR - KMS-890K895987KELLER PULSE OXIMETER - KMS 850

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

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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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