The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Phox Plus L Analyzer.
| Device ID | K012058 |
| 510k Number | K012058 |
| Device Name: | STAT PROFILE PHOX PLUS L 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 | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIP |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480347171 | K012058 | 000 |
| 10385480340813 | K012058 | 000 |
| 00385480340854 | K012058 | 000 |
| 00385480340861 | K012058 | 000 |
| 00385480340878 | K012058 | 000 |
| 00385480340885 | K012058 | 000 |
| 00385480340908 | K012058 | 000 |
| 00385480340915 | K012058 | 000 |
| 00385480340922 | K012058 | 000 |
| 00385480340939 | K012058 | 000 |
| 00385480134095 | K012058 | 000 |