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FDA 510(k)

INSIGHT GENESIS

K-Number: K011983 · 2001-08-30

ApplicantFasstech
Decision Date2001-08-30
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INSIGHT GENESIS is the device name listed in this FDA 510(k) record. The listed applicant is Fasstech. It received FDA 510(k) clearance on 2001-08-30 under 510(k) number K011983. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGHT GENESIS?

INSIGHT GENESIS is a medical device that received FDA 510(k) clearance on 2001-08-30. The listed applicant is Fasstech. The 510(k) number is K011983.

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

INSIGHT GENESIS received FDA 510(k) clearance on 2001-08-30, under 510(k) number K011983.

Who is the listed applicant for INSIGHT GENESIS?

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 GENESIS?

The FDA product code for INSIGHT GENESIS is HCC.

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.

K063447INSIGHT DISCOVERYK033452CWAS 1000K023209INSIGHT MILLENNIUM IIIK011964INSIGHT MILLENNIUM PLUSK990778INSIGHT MILLENNIUMK961212SPINAL TOUCH

View all 9 devices →

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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