The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Abg Analyzer System.
| Device ID | K151982 |
| 510k Number | K151982 |
| Device Name: | Stat Profile Prime ABG Analyzer System |
| 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 |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-17 |
| Decision Date | 2015-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480567268 | K151982 | 000 |
| 00385480526173 | K151982 | 000 |
| 00385480527149 | K151982 | 000 |
| 00385480531047 | K151982 | 000 |
| 00385480531078 | K151982 | 000 |
| 00385480531085 | K151982 | 000 |
| 00385480533591 | K151982 | 000 |
| 00385480533607 | K151982 | 000 |
| 00385480534567 | K151982 | 000 |
| 00385480534635 | K151982 | 000 |
| 00385480534642 | K151982 | 000 |
| 00385480536554 | K151982 | 000 |
| 10385480552629 | K151982 | 000 |
| 00385480567251 | K151982 | 000 |
| 10385480420317 | K151982 | 000 |