The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Critical Care Xpress Analyzer.
| Device ID | K020297 |
| 510k Number | K020297 |
| Device Name: | STAT PROFILE CRITICAL CARE XPRESS 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 |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480379595 | K020297 | 000 |
| 00385480371643 | K020297 | 000 |
| 00385480366403 | K020297 | 000 |
| 00385480362511 | K020297 | 000 |