FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Carbon Monoxide Breath Sensor System (COBSS)
K Number: K171408
·
Decision Sep 29, 2017
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
1
Review Days
140
Basic Information
- Device Name
- Carbon Monoxide Breath Sensor System (COBSS)
- K Number
- K171408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carrot Sense, Inc.
- Date Received
- May 12, 2017
- Decision Date
- September 29, 2017
- Product Code
- CCJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- TX
- 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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