The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Abg Analyzer System (incl. Controls, Calibrators).
| Device ID | K142220 |
| 510k Number | K142220 |
| Device Name: | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 PROSPECT ST. Waltham, MA 02454 |
| Contact | Paul W. Macdonald |
| Correspondent | Paul W. Macdonald NOVA BIOMEDICAL CORPORATION 200 PROSPECT ST. Waltham, MA 02454 |
| Product Code | CHL |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJS |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-12 |
| Decision Date | 2014-10-17 |
| Summary: | summary |