Nova Stat Profile Phox Ultra Analyzer System
FDA 510(k) K110648 · Nova Biomedical Corporation
510(k) numberK110648
Submission
- Device name
- Nova Stat Profile Phox Ultra Analyzer System
- Applicant
- Nova Biomedical Corporation
Waltham, MA, US - Received
- March 4, 2011
- Decision date
- August 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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Questions and answers
When was Nova Stat Profile Phox Ultra Analyzer System cleared by the FDA?
Nova Stat Profile Phox Ultra Analyzer System (K110648) received a 510(k) decision of Substantially Equivalent on August 29, 2011, 178 days after the submission was received.
What is the product code of K110648?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.