The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Co-stat(tm) End Tidal Breath Analyzer.
| Device ID | K974805 |
| 510k Number | K974805 |
| Device Name: | CO-STAT(TM) END TIDAL BREATH ANALYZER |
| Classification | Assay, Carboxyhemoglobin |
| Applicant | NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Esther Kadash |
| Correspondent | Esther Kadash NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | GHS |
| Subsequent Product Code | CCJ |
| Subsequent Product Code | CCK |
| CFR Regulation Number | 864.7425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-03-11 |
| Summary: | summary |