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FDA 510(k)

STAODYN MAX PRESET, MODEL 4470

K-Number: K061516 · 2007-02-06

ApplicantCompex Technologies, Inc.
Decision Date2007-02-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STAODYN MAX PRESET, MODEL 4470 is the device name listed in this FDA 510(k) record. The listed applicant is Compex Technologies, Inc.. It received FDA 510(k) clearance on 2007-02-06 under 510(k) number K061516. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAODYN MAX PRESET, MODEL 4470?

STAODYN MAX PRESET, MODEL 4470 is a medical device that received FDA 510(k) clearance on 2007-02-06. The listed applicant is Compex Technologies, Inc.. The 510(k) number is K061516.

When did STAODYN MAX PRESET, MODEL 4470 receive FDA 510(k) clearance?

STAODYN MAX PRESET, MODEL 4470 received FDA 510(k) clearance on 2007-02-06, under 510(k) number K061516.

Who is the listed applicant for STAODYN MAX PRESET, MODEL 4470?

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

What is the FDA product code for STAODYN MAX PRESET, MODEL 4470?

The FDA product code for STAODYN MAX PRESET, MODEL 4470 is GZJ.

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Other records listing Compex Technologies, 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.

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Related Devices (Code: GZJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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