Co-Stat(Tm) End Tidal Breath Analyzer
FDA 510(k) K974805 · Natus Medical, Inc.
510(k) numberK974805
Submission
- Device name
- Co-Stat(Tm) End Tidal Breath Analyzer
- Applicant
- Natus Medical, Inc.
San Carlos, CA, US - Received
- December 23, 1997
- Decision date
- March 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GHS – Assay, Carboxyhemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7425
- Specialty
- Hematology
Other 510(k)s with product code GHS
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|---|---|---|---|
| K910827 | ABL520 Blood Gas SystemGHS · Traditional | Radiometer America, Inc. | 07/09/1991SE |
| K790943 | Trisedta-Borate Electrophoresis Film AgaGHS · Traditional | Corning Medical & Scientific | 06/22/1979SE |
| K771263 | Radiomhter OSM-2 HemoximeterGHS · Traditional | The London Co. | 08/03/1977SE |
| K770209 | Ecolyzer CarboximeterGHS · Traditional | Iadec, Inc. | 03/07/1977SE |
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Questions and answers
When was Co-Stat(Tm) End Tidal Breath Analyzer cleared by the FDA?
Co-Stat(Tm) End Tidal Breath Analyzer (K974805) received a 510(k) decision of Substantially Equivalent on March 11, 1998, 78 days after the submission was received.
What is the product code of K974805?
The FDA product code is GHS – Assay, Carboxyhemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7425.