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FDA 510(k)

WRIST ACTIGRAPH

K-Number: K854030 · 1986-06-25

ApplicantAmbulatory Monitoring, Inc.
Decision Date1986-06-25
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WRIST ACTIGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Ambulatory Monitoring, Inc.. It received FDA 510(k) clearance on 1986-06-25 under 510(k) number K854030. 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 WRIST ACTIGRAPH?

WRIST ACTIGRAPH is a medical device that received FDA 510(k) clearance on 1986-06-25. The listed applicant is Ambulatory Monitoring, Inc.. The 510(k) number is K854030.

When did WRIST ACTIGRAPH receive FDA 510(k) clearance?

WRIST ACTIGRAPH received FDA 510(k) clearance on 1986-06-25, under 510(k) number K854030.

Who is the listed applicant for WRIST ACTIGRAPH?

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

What is the FDA product code for WRIST ACTIGRAPH?

The FDA product code for WRIST ACTIGRAPH is GWQ.

Related Clinical Trials

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Other records listing Ambulatory Monitoring, 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.

K251574Sleep WatchK894044ACTILLUME

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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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