Ciba Corning Model 238 Ph/ Blood Gas Analyzer
FDA 510(k) K904188 · Ciba Corning Diagnostics Corp.
510(k) numberK904188
Submission
- Device name
- Ciba Corning Model 238 Ph/ Blood Gas Analyzer
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- September 12, 1990
- Decision date
- September 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ciba Corning Model 238 Ph/ Blood Gas Analyzer cleared by the FDA?
Ciba Corning Model 238 Ph/ Blood Gas Analyzer (K904188) received a 510(k) decision of Substantially Equivalent on September 27, 1990, 15 days after the submission was received.
What is the product code of K904188?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.