Oxygen Analyzer 110
FDA 510(k) K780185 · Siemens Corp.
510(k) numberK780185
Submission
- Device name
- Oxygen Analyzer 110
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- February 6, 1978
- Decision date
- March 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1150
- Specialty
- Anesthesiology
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Questions and answers
When was Oxygen Analyzer 110 cleared by the FDA?
Oxygen Analyzer 110 (K780185) received a 510(k) decision of Substantially Equivalent on March 17, 1978, 39 days after the submission was received.
What is the product code of K780185?
The FDA product code is CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1150.