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FDA 510(k)

AMENDMENT LIFEPAK 8, NPN 052

K-Number: K854117 · 1986-01-13

ApplicantPhysio-Control Corp.
Decision Date1986-01-13
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMENDMENT LIFEPAK 8, NPN 052 is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K854117. 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 AMENDMENT LIFEPAK 8, NPN 052?

AMENDMENT LIFEPAK 8, NPN 052 is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Physio-Control Corp.. The 510(k) number is K854117.

When did AMENDMENT LIFEPAK 8, NPN 052 receive FDA 510(k) clearance?

AMENDMENT LIFEPAK 8, NPN 052 received FDA 510(k) clearance on 1986-01-13, under 510(k) number K854117.

Who is the listed applicant for AMENDMENT LIFEPAK 8, NPN 052?

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

What is the FDA product code for AMENDMENT LIFEPAK 8, NPN 052?

The FDA product code for AMENDMENT LIFEPAK 8, NPN 052 is DRO.

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Other records listing Physio-Control 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.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

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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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