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FDA 510(k)

ACTILLUME

K-Number: K894044 · 1989-12-22

ApplicantAmbulatory Monitoring, Inc.
Decision Date1989-12-22
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTILLUME 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 1989-12-22 under 510(k) number K894044. 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 ACTILLUME?

ACTILLUME is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Ambulatory Monitoring, Inc.. The 510(k) number is K894044.

When did ACTILLUME receive FDA 510(k) clearance?

ACTILLUME received FDA 510(k) clearance on 1989-12-22, under 510(k) number K894044.

Who is the listed applicant for ACTILLUME?

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 ACTILLUME?

The FDA product code for ACTILLUME is GWQ.

Related Clinical Trials

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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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 WatchK854030WRIST ACTIGRAPH

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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