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FDA 510(k)

LIFEPAK 12 BIPHASIC

K-Number: K991910 · 1999-09-03

ApplicantPhysio-Control Corp.
Decision Date1999-09-03
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

LIFEPAK 12 BIPHASIC 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 1999-09-03 under 510(k) number K991910. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the LIFEPAK 12 BIPHASIC?

LIFEPAK 12 BIPHASIC is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Physio-Control Corp.. The 510(k) number is K991910.

When did LIFEPAK 12 BIPHASIC receive FDA 510(k) clearance?

LIFEPAK 12 BIPHASIC received FDA 510(k) clearance on 1999-09-03, under 510(k) number K991910.

Who is the listed applicant for LIFEPAK 12 BIPHASIC?

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 LIFEPAK 12 BIPHASIC?

The FDA product code for LIFEPAK 12 BIPHASIC is MKJ. This falls under the Dental category.

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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.

K990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500K953204PEDIATRIC QUIK-COMBO

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Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

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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