K955013 is an FDA 510(k) clearance for the NOVA CO-OXIMETER ANALYZER. This device is classified as a Oximeter To Measure Hemoglobin (Class II - Special Controls, product code GLY).
Submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on April 25, 1996, 176 days after receiving the submission on November 1, 1995.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7500.
| 510(k) Number | K955013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1995 |
| Decision Date | April 25, 1996 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GLY — Oximeter To Measure Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7500 |