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FDA 510(k)

ACTIWATCH

K-Number: K983533 · 1999-03-23

ApplicantMini-Mitter Co., Inc.
Decision Date1999-03-23
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTIWATCH is the device name listed in this FDA 510(k) record. The listed applicant is Mini-Mitter Co., Inc.. It received FDA 510(k) clearance on 1999-03-23 under 510(k) number K983533. 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 ACTIWATCH?

ACTIWATCH is a medical device that received FDA 510(k) clearance on 1999-03-23. The listed applicant is Mini-Mitter Co., Inc.. The 510(k) number is K983533.

When did ACTIWATCH receive FDA 510(k) clearance?

ACTIWATCH received FDA 510(k) clearance on 1999-03-23, under 510(k) number K983533.

Who is the listed applicant for ACTIWATCH?

The FDA 510(k) record lists Mini-Mitter Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIWATCH?

The FDA product code for ACTIWATCH 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mini-Mitter Co., 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.

K033534VITALSENSEK011430ACTIWARE-PLMSK991045MINI-LOGGER SERIES 2000K991033ACTIWATCH-SCORE

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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