The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Phox Co-oximeter Analyzer, Nova Co-oximeter Controls, Levels 1 And 2, Nova Co-oximeter Thb Calibrator.
| Device ID | K993104 |
| 510k Number | K993104 |
| Device Name: | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR |
| Classification | Oximeter To Measure Hemoglobin |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Mac Donald |
| Correspondent | Paul W Mac Donald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | GLY |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480333433 | K993104 | 000 |
| 00385480280006 | K993104 | 000 |
| 00385480279499 | K993104 | 000 |
| 00385480268653 | K993104 | 000 |
| 00385480250559 | K993104 | 000 |
| 00385480180986 | K993104 | 000 |