The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Ultra 11 Analyzer.
| Device ID | K943643 |
| 510k Number | K943643 |
| Device Name: | STAT PROFILE ULTRA 11 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 | CEM |
| Subsequent Product Code | CFA |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JPI |
| Subsequent Product Code | JPK |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-27 |
| Decision Date | 1994-12-29 |