The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Nova Stat Profile Phox Ultra Analyzer System.
| Device ID | K110648 |
| 510k Number | K110648 |
| Device Name: | NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 PROSPECT ST. Waltham, MA 02453 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORPORATION 200 PROSPECT ST. Waltham, MA 02453 |
| Product Code | CHL |
| Subsequent Product Code | BXX |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFA |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGL |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GGZ |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GJC |
| Subsequent Product Code | GKK |
| Subsequent Product Code | GLY |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJB |
| Subsequent Product Code | NGD |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-08-29 |
| Summary: | summary |