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FDA 510(k)

PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR

K-Number: K946080 · 1995-08-02

ApplicantPortable Power Systems, Inc.
Decision Date1995-08-02
Product CodeFCO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Portable Power Systems, Inc.. It received FDA 510(k) clearance on 1995-08-02 under 510(k) number K946080. The device is classified under product code FCO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR?

PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1995-08-02. The listed applicant is Portable Power Systems, Inc.. The 510(k) number is K946080.

When did PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR receive FDA 510(k) clearance?

PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR received FDA 510(k) clearance on 1995-08-02, under 510(k) number K946080.

Who is the listed applicant for PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR?

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

What is the FDA product code for PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR?

The FDA product code for PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR is FCO.

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Other records listing Portable Power Systems, Inc. as applicant

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Related Devices (Code: FCO)

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.

K945870R&D PART NOS. 5490, 5541, 5358, 5497R & D Batteries, Inc.K944388R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100R & D Batteries, Inc.K944348R&D BATTERIES, INC. PART NO. 5128, 5053, 5007R & D Batteries, Inc.K944389R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153R & D Batteries, Inc.K945868R&D PART NOS. 5262, 5543, 5432, 5469R & D Batteries, Inc.K944521RECHARGEABLE BATTERIESR & D Batteries, 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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