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FDA 510(k)

I-BEAM

K-Number: K032100 · 2003-10-02

ApplicantComputerized Medical Systems, Inc.
Decision Date2003-10-02
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-BEAM is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-10-02 under 510(k) number K032100. 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 I-BEAM?

I-BEAM is a medical device that received FDA 510(k) clearance on 2003-10-02. The listed applicant is Computerized Medical Systems, Inc.. The 510(k) number is K032100.

When did I-BEAM receive FDA 510(k) clearance?

I-BEAM received FDA 510(k) clearance on 2003-10-02, under 510(k) number K032100.

Who is the listed applicant for I-BEAM?

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

What is the FDA product code for I-BEAM?

The FDA product code for I-BEAM is IYE.

Other records listing Computerized Medical Systems, Inc. as applicant

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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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