K014295 is an FDA 510(k) clearance for the STAT PROFILE PHOX ANALYZER. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on February 28, 2002, 62 days after receiving the submission on December 28, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K014295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2001 |
| Decision Date | February 28, 2002 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |