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FDA 510(k)

EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK

K-Number: K960957 · 1996-06-04

ApplicantSims Deltec, Inc.
Decision Date1996-06-04
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1996-06-04 under 510(k) number K960957. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK?

EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK is a medical device that received FDA 510(k) clearance on 1996-06-04. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K960957.

When did EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK receive FDA 510(k) clearance?

EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK received FDA 510(k) clearance on 1996-06-04, under 510(k) number K960957.

Who is the listed applicant for EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK?

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

What is the FDA product code for EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK?

The FDA product code for EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK is FRN.

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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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