Il 801 Thermaldilution Cardiac Output
FDA 510(k) K822972 · Instrumentation Laboratory CO
510(k) numberK822972
Submission
- Device name
- Il 801 Thermaldilution Cardiac Output
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- October 8, 1982
- Decision date
- November 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
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Questions and answers
When was Il 801 Thermaldilution Cardiac Output cleared by the FDA?
Il 801 Thermaldilution Cardiac Output (K822972) received a 510(k) decision of Substantially Equivalent on November 1, 1982, 24 days after the submission was received.
What is the product code of K822972?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.