FDA 510(k)

IBD-SCAN

K-Number: K042071 · 2004-10-20

Decision Date2004-10-20

Product CodeDEG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

IBD-SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K042071. The device is classified under product code DEG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBD-SCAN?

IBD-SCAN is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Techlab, Inc.. The 510(k) number is K042071.

When did IBD-SCAN receive FDA 510(k) clearance?

IBD-SCAN received FDA 510(k) clearance on 2004-10-20, under 510(k) number K042071.

Who is the listed applicant for IBD-SCAN?

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

What is the FDA product code for IBD-SCAN?

The FDA product code for IBD-SCAN is DEG.

Other records listing Techlab, Inc. as applicant

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Related Devices (Code: DEG)

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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.