FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
iCOquit® Smokerlyzer®
K Number: K211918
·
Decision Dec 21, 2021
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
3
Review Days
183
Basic Information
- Device Name
- iCOquit® Smokerlyzer®
- K Number
- K211918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bedfont Scientific Ltd
- Date Received
- June 21, 2021
- Decision Date
- December 21, 2021
- Product Code
- CCJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- TX
- Third Party
- Y
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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