Veo Multigas Monitor for Pocket PC, Model 400221

FDA 510(k) K051857 · Weissburg Associates

Substantially Equivalent

510(k) numberK051857

Submission

Device name
Veo Multigas Monitor for Pocket PC, Model 400221
Applicant
Weissburg Associates
Madison, WI, US
Received
July 8, 2005
Decision date
September 15, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1400
Specialty
Anesthesiology

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Questions and answers

When was Veo Multigas Monitor for Pocket PC, Model 400221 cleared by the FDA?

Veo Multigas Monitor for Pocket PC, Model 400221 (K051857) received a 510(k) decision of Substantially Equivalent on September 15, 2005, 69 days after the submission was received.

What is the product code of K051857?

The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.