Veo Multigas Monitor for Pocket PC
FDA 510(k) K081601 · Phasein AB
510(k) numberK081601
Submission
- Device name
- Veo Multigas Monitor for Pocket PC
- Applicant
- Phasein AB
Madison, WI, US - Received
- June 6, 2008
- Decision date
- September 4, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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More from Southmedic, Inc.
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Questions and answers
When was Veo Multigas Monitor for Pocket PC cleared by the FDA?
Veo Multigas Monitor for Pocket PC (K081601) received a 510(k) decision of Substantially Equivalent on September 4, 2008, 90 days after the submission was received.
What is the product code of K081601?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.