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FDA 510(k)

RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB

K-Number: K934015 · 1994-02-17

ApplicantPortable Power Systems, Inc.
Decision Date1994-02-17
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB 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 1994-02-17 under 510(k) number K934015. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB?

RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB is a medical device that received FDA 510(k) clearance on 1994-02-17. The listed applicant is Portable Power Systems, Inc.. The 510(k) number is K934015.

When did RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB receive FDA 510(k) clearance?

RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB received FDA 510(k) clearance on 1994-02-17, under 510(k) number K934015.

Who is the listed applicant for RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB?

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 RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB?

The FDA product code for RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB is LDD.

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Other records listing Portable Power Systems, Inc. as applicant

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K970234SEALED LEAD ACID BATTERY PACKK946080PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATORK945043BATTERY PACK #PMX120-18AK933065BATTERY PACK# S1009LAK934439RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITORK934508BATTERY PACK# S1024NC

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Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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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