FDA 510(k)

PK SUPERPULSE SYSEM GENERATOR MODEL 744000

K-Number: K100816 · 2010-07-01

Decision Date2010-07-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PK SUPERPULSE SYSEM GENERATOR MODEL 744000 is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2010-07-01 under 510(k) number K100816. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PK SUPERPULSE SYSEM GENERATOR MODEL 744000?

PK SUPERPULSE SYSEM GENERATOR MODEL 744000 is a medical device that received FDA 510(k) clearance on 2010-07-01. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K100816.

When did PK SUPERPULSE SYSEM GENERATOR MODEL 744000 receive FDA 510(k) clearance?

PK SUPERPULSE SYSEM GENERATOR MODEL 744000 received FDA 510(k) clearance on 2010-07-01, under 510(k) number K100816.

Who is the listed applicant for PK SUPERPULSE SYSEM GENERATOR MODEL 744000?

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

What is the FDA product code for PK SUPERPULSE SYSEM GENERATOR MODEL 744000?

The FDA product code for PK SUPERPULSE SYSEM GENERATOR MODEL 744000 is GEI.

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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.