Viridia Information Center Software for M3154A Opt C22

FDA 510(k) K993907 · Agilent Technologies, Inc.

Substantially Equivalent

510(k) numberK993907

Submission

Device name
Viridia Information Center Software for M3154A Opt C22
Applicant
Agilent Technologies, Inc.
Andover, MA, US
Received
November 17, 1999
Decision date
December 6, 1999
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MHD – Pump, Infusion, Gallstone Dissolution
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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Questions and answers

When was Viridia Information Center Software for M3154A Opt C22 cleared by the FDA?

Viridia Information Center Software for M3154A Opt C22 (K993907) received a 510(k) decision of Substantially Equivalent on December 6, 1999, 19 days after the submission was received.

What is the product code of K993907?

The FDA product code is MHD – Pump, Infusion, Gallstone Dissolution, a Class II (moderate risk) device regulated under 21 CFR 880.5725.