The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Plus 10 Analyzer.
| Device ID | K936203 |
| 510k Number | K936203 |
| Device Name: | STAT PROFILE PLUS 10 ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | CHL |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-21 |
| Decision Date | 1995-03-09 |