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FDA 510(k)

MEDIC COLON MODEL, RELEASE 1

K-Number: K033102 · 2003-11-05

ApplicantMedicsight
Decision Date2003-11-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDIC COLON MODEL, RELEASE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Medicsight. It received FDA 510(k) clearance on 2003-11-05 under 510(k) number K033102. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIC COLON MODEL, RELEASE 1?

MEDIC COLON MODEL, RELEASE 1 is a medical device that received FDA 510(k) clearance on 2003-11-05. The listed applicant is Medicsight. The 510(k) number is K033102.

When did MEDIC COLON MODEL, RELEASE 1 receive FDA 510(k) clearance?

MEDIC COLON MODEL, RELEASE 1 received FDA 510(k) clearance on 2003-11-05, under 510(k) number K033102.

Who is the listed applicant for MEDIC COLON MODEL, RELEASE 1?

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

What is the FDA product code for MEDIC COLON MODEL, RELEASE 1?

The FDA product code for MEDIC COLON MODEL, RELEASE 1 is JAK.

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 Medicsight 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.

K042674COLON CAR 1.2K041807LUNG CAR 1.1K033412MEDICLUNG, RELEASE 1K032823MEDICHEART, MODEL RELEASE 1

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, 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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