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FDA 510(k)

PACEPAC

K-Number: K852958 · 1985-10-11

ApplicantMedical Data Electronics
Decision Date1985-10-11
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEPAC is the device name listed in this FDA 510(k) record. The listed applicant is Medical Data Electronics. It received FDA 510(k) clearance on 1985-10-11 under 510(k) number K852958. 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 PACEPAC?

PACEPAC is a medical device that received FDA 510(k) clearance on 1985-10-11. The listed applicant is Medical Data Electronics. The 510(k) number is K852958.

When did PACEPAC receive FDA 510(k) clearance?

PACEPAC received FDA 510(k) clearance on 1985-10-11, under 510(k) number K852958.

Who is the listed applicant for PACEPAC?

The FDA 510(k) record lists Medical Data Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACEPAC?

The FDA product code for PACEPAC is DRO.

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Other records listing Medical Data Electronics 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.

K014294MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414K012336MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413K992413ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITORK992411ESCORT II+ 400 SERIES (ESCORT PRISM) MONITORK982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500

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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

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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