FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoSense ETCO Monitor
K Number: K253119
·
Decision May 29, 2026
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
27
Applicant Total
4
Review Days
247
Basic Information
- Device Name
- CoSense ETCO Monitor
- K Number
- K253119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Capnia, Inc.
- Date Received
- September 24, 2025
- Decision Date
- May 29, 2026
- Product Code
- CCJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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