FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AcuPebble OX100
K Number: K222950
·
Decision Feb 3, 2023
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
3
Review Days
129
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Basic Information
- Device Name
- AcuPebble OX100
- K Number
- K222950
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acurable Limited
- Date Received
- September 27, 2022
- Decision Date
- February 3, 2023
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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