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FDA 510(k)

GELSCAN, MODEL 1206

K-Number: K100307 · 2010-08-31

ApplicantSebia
Decision Date2010-08-31
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GELSCAN, MODEL 1206 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K100307. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELSCAN, MODEL 1206?

GELSCAN, MODEL 1206 is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Sebia. The 510(k) number is K100307.

When did GELSCAN, MODEL 1206 receive FDA 510(k) clearance?

GELSCAN, MODEL 1206 received FDA 510(k) clearance on 2010-08-31, under 510(k) number K100307.

Who is the listed applicant for GELSCAN, MODEL 1206?

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

What is the FDA product code for GELSCAN, MODEL 1206?

The FDA product code for GELSCAN, MODEL 1206 is CFE.

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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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