Acueity Medical Light Source

FDA 510(k) K032430 · Acueity, Inc.

Substantially Equivalent

510(k) numberK032430

Submission

Device name
Acueity Medical Light Source
Applicant
Acueity, Inc.
Palo Alto, CA, US
Received
August 6, 2003
Decision date
September 5, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
FCW – Light Source, Fiberoptic, Routine
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

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Questions and answers

When was Acueity Medical Light Source cleared by the FDA?

Acueity Medical Light Source (K032430) received a 510(k) decision of Substantially Equivalent on September 5, 2003, 30 days after the submission was received.

What is the product code of K032430?

The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.