Submission Details
| 510(k) Number | K023567 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 2002 |
| Decision Date | December 20, 2002 |
| Days to Decision | 58 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Abbreviated
STAT PROFILE PHOX PLUS L ANALYZER
Dec 2002
Decision
58d
Days
Class 2
Risk
About This 510(k) Submission
K023567 is an FDA 510(k) clearance for the STAT PROFILE PHOX PLUS L ANALYZER, 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 December 20, 2002, 58 days after receiving the submission on October 23, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.
Device Classification
| Product Code | CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1120 |
Manufacturer
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