Il BG3 Syst, Model 1420, Blood Gas & PH Test Syst
FDA 510(k) K913927 · Instrumentation Laboratory CO
510(k) numberK913927
Submission
- Device name
- Il BG3 Syst, Model 1420, Blood Gas & PH Test Syst
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- September 3, 1991
- Decision date
- October 11, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Il BG3 Syst, Model 1420, Blood Gas & PH Test Syst cleared by the FDA?
Il BG3 Syst, Model 1420, Blood Gas & PH Test Syst (K913927) received a 510(k) decision of Substantially Equivalent on October 11, 1991, 38 days after the submission was received.
What is the product code of K913927?
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.