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FDA 510(k)

2 BASIC

K-Number: K030175 · 2003-04-17

ApplicantCapintec, Inc.
Decision Date2003-04-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

2 BASIC is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2003-04-17 under 510(k) number K030175. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2 BASIC?

2 BASIC is a medical device that received FDA 510(k) clearance on 2003-04-17. The listed applicant is Capintec, Inc.. The 510(k) number is K030175.

When did 2 BASIC receive FDA 510(k) clearance?

2 BASIC received FDA 510(k) clearance on 2003-04-17, under 510(k) number K030175.

Who is the listed applicant for 2 BASIC?

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

What is the FDA product code for 2 BASIC?

The FDA product code for 2 BASIC is IYE.

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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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