The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Co-oximeter Analyzer.
| Device ID | K955013 |
| 510k Number | K955013 |
| Device Name: | NOVA CO-OXIMETER ANALYZER |
| 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 | 1995-11-01 |
| Decision Date | 1996-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480181006 | K955013 | 000 |
| 00385480180993 | K955013 | 000 |