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FDA 510(k)

R2 PACE PAD, MODEL 480

K-Number: K895729 · 1989-10-12

ApplicantDarox Corp.
Decision Date1989-10-12
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R2 PACE PAD, MODEL 480 is the device name listed in this FDA 510(k) record. The listed applicant is Darox Corp.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K895729. 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 R2 PACE PAD, MODEL 480?

R2 PACE PAD, MODEL 480 is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Darox Corp.. The 510(k) number is K895729.

When did R2 PACE PAD, MODEL 480 receive FDA 510(k) clearance?

R2 PACE PAD, MODEL 480 received FDA 510(k) clearance on 1989-10-12, under 510(k) number K895729.

Who is the listed applicant for R2 PACE PAD, MODEL 480?

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

What is the FDA product code for R2 PACE PAD, MODEL 480?

The FDA product code for R2 PACE PAD, MODEL 480 is DRO.

Related Clinical Trials

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Other records listing Darox Corp. 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.

K895728R2 PACE ADAPTOR CABLE, MODEL 196

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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