Capnography Pad (92516)
FDA 510(k) K121017 · Spacelabs Healthcare
510(k) numberK121017
Submission
- Device name
- Capnography Pad (92516)
- Applicant
- Spacelabs Healthcare
Nederland, CO, US - Received
- April 4, 2012
- Decision date
- July 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was Capnography Pad (92516) cleared by the FDA?
Capnography Pad (92516) (K121017) received a 510(k) decision of Substantially Equivalent on July 13, 2012, 100 days after the submission was received.
What is the product code of K121017?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.