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FDA 510(k)

INSIGHT DISCOVERY

K-Number: K063447 · 2007-08-16

ApplicantFasstech
Decision Date2007-08-16
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INSIGHT DISCOVERY is the device name listed in this FDA 510(k) record. The listed applicant is Fasstech. It received FDA 510(k) clearance on 2007-08-16 under 510(k) number K063447. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGHT DISCOVERY?

INSIGHT DISCOVERY is a medical device that received FDA 510(k) clearance on 2007-08-16. The listed applicant is Fasstech. The 510(k) number is K063447.

When did INSIGHT DISCOVERY receive FDA 510(k) clearance?

INSIGHT DISCOVERY received FDA 510(k) clearance on 2007-08-16, under 510(k) number K063447.

Who is the listed applicant for INSIGHT DISCOVERY?

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

What is the FDA product code for INSIGHT DISCOVERY?

The FDA product code for INSIGHT DISCOVERY is IKN.

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 Fasstech 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.

K033452CWAS 1000K023209INSIGHT MILLENNIUM IIIK011964INSIGHT MILLENNIUM PLUSK011983INSIGHT GENESISK990778INSIGHT MILLENNIUMK961212SPINAL TOUCH

View all 9 devices →

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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