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FDA 510(k)

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

K-Number: K983196 · 1999-09-15

ApplicantTz Medical, Inc.
Decision Date1999-09-15
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) is the device name listed in this FDA 510(k) record. The listed applicant is Tz Medical, Inc.. It received FDA 510(k) clearance on 1999-09-15 under 510(k) number K983196. 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 PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)?

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) is a medical device that received FDA 510(k) clearance on 1999-09-15. The listed applicant is Tz Medical, Inc.. The 510(k) number is K983196.

When did PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) receive FDA 510(k) clearance?

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) received FDA 510(k) clearance on 1999-09-15, under 510(k) number K983196.

Who is the listed applicant for PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)?

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

What is the FDA product code for PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)?

The FDA product code for PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) is DRO.

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Other records listing Tz Medical, 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.

K252772Arc Adjustable Radial Cuff Compression DeviceK173563ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICEK163322TZ SKULL PIN AdultK102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTORK062577V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPCK040208NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND

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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.

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 ElectronicsK983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, Inc.K962547CARDIOSERV PMarquette Electronics, 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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