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 |