FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Enlight 2100
K Number: K222897
·
Decision Mar 7, 2023
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
3
Review Days
165
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Basic Information
- Device Name
- Enlight 2100
- K Number
- K222897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1505
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Timpel S.A.
- Date Received
- September 23, 2022
- Decision Date
- March 7, 2023
- Product Code
- QEB
- 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 |
|---|---|---|---|
| QEB | Ventilatory Electrical Impedance Tomograph | FDA class 2 | Anesthesiology |
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