Oxygen Monitor Il 408
FDA 510(k) K823374 · Instrumentation Laboratory CO
510(k) numberK823374
Submission
- Device name
- Oxygen Monitor Il 408
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- November 12, 1982
- Decision date
- December 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
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Questions and answers
When was Oxygen Monitor Il 408 cleared by the FDA?
Oxygen Monitor Il 408 (K823374) received a 510(k) decision of Substantially Equivalent on December 9, 1982, 27 days after the submission was received.
What is the product code of K823374?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.