AB O2 Consumption Calculator 980
FDA 510(k) K802417 · Siemens Elema AB
510(k) numberK802417
Submission
- Device name
- AB O2 Consumption Calculator 980
- Applicant
- Siemens Elema AB
Mchenry, IL, US - Received
- October 6, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZL – Computer, Oxygen-Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1730
- Specialty
- Anesthesiology
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Questions and answers
When was AB O2 Consumption Calculator 980 cleared by the FDA?
AB O2 Consumption Calculator 980 (K802417) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 17 days after the submission was received.
What is the product code of K802417?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.