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FDA 510(k)

EXTERNAL PACEMAKER 2000 (EP2000)

K-Number: K882168 · 1988-08-19

ApplicantUnomed, Inc.
Decision Date1988-08-19
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL PACEMAKER 2000 (EP2000) is the device name listed in this FDA 510(k) record. The listed applicant is Unomed, Inc.. It received FDA 510(k) clearance on 1988-08-19 under 510(k) number K882168. 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 EXTERNAL PACEMAKER 2000 (EP2000)?

EXTERNAL PACEMAKER 2000 (EP2000) is a medical device that received FDA 510(k) clearance on 1988-08-19. The listed applicant is Unomed, Inc.. The 510(k) number is K882168.

When did EXTERNAL PACEMAKER 2000 (EP2000) receive FDA 510(k) clearance?

EXTERNAL PACEMAKER 2000 (EP2000) received FDA 510(k) clearance on 1988-08-19, under 510(k) number K882168.

Who is the listed applicant for EXTERNAL PACEMAKER 2000 (EP2000)?

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

What is the FDA product code for EXTERNAL PACEMAKER 2000 (EP2000)?

The FDA product code for EXTERNAL PACEMAKER 2000 (EP2000) is DRO.

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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.

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

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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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