K002613 is an FDA 510(k) clearance for the MODIFICATION TO STAT PROFILE PHOX PLUS 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 October 19, 2000, 58 days after receiving the submission on August 22, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K002613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2000 |
| Decision Date | October 19, 2000 |
| Days to Decision | 58 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 |