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FDA 510(k)

ACTICAL

K-Number: K060919 · 2006-09-22

ApplicantRespironics, Inc.
Decision Date2006-09-22
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTICAL is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2006-09-22 under 510(k) number K060919. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTICAL?

ACTICAL is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Respironics, Inc.. The 510(k) number is K060919.

When did ACTICAL receive FDA 510(k) clearance?

ACTICAL received FDA 510(k) clearance on 2006-09-22, under 510(k) number K060919.

Who is the listed applicant for ACTICAL?

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

What is the FDA product code for ACTICAL?

The FDA product code for ACTICAL is GWK.

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Related PubMed Literature

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PMID: 41966058Artificial intelligence in personalized prescription: A narrative review of promise, peril, and practicality.Therapie ()PMID: 37579360Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".International journal of health policy and management ()

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Related Devices (Code: GWK)

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.

K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K991045MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.K896164ASC-954 INTEGRATOR AMPLIFIERAstro-Med, Inc.

Official Source

View on FDA Database →

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

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