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FDA 510(k)

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10

K-Number: K934067 · 1993-10-07

ApplicantNational Custom Ent., Inc.
Decision Date1993-10-07
Product CodeDRK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 is the device name listed in this FDA 510(k) record. The listed applicant is National Custom Ent., Inc.. It received FDA 510(k) clearance on 1993-10-07 under 510(k) number K934067. The device is classified under product code DRK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10?

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 is a medical device that received FDA 510(k) clearance on 1993-10-07. The listed applicant is National Custom Ent., Inc.. The 510(k) number is K934067.

When did POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 receive FDA 510(k) clearance?

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 received FDA 510(k) clearance on 1993-10-07, under 510(k) number K934067.

Who is the listed applicant for POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10?

The FDA 510(k) record lists National Custom Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10?

The FDA product code for POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 is DRK.

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Other records listing National Custom Ent., Inc. 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.

K012263MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024K012264MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWCK012266SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2K012262BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WCK012259MEDFUSION 2001 & 2010, MODEL N7215IWCK012229SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC

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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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