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FDA 510(k)

ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256

K-Number: K040554 · 2004-07-16

ApplicantManufacturing Technology, Inc.
Decision Date2004-07-16
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 is the device name listed in this FDA 510(k) record. The listed applicant is Manufacturing Technology, Inc.. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K040554. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256?

ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Manufacturing Technology, Inc.. The 510(k) number is K040554.

When did ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 receive FDA 510(k) clearance?

ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 received FDA 510(k) clearance on 2004-07-16, under 510(k) number K040554.

Who is the listed applicant for ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256?

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

What is the FDA product code for ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256?

The FDA product code for ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 is GWQ.

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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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