FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Enlight 2100
K Number: K211135
·
Decision Jan 6, 2022
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
3
Review Days
265
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Enlight 2100
- K Number
- K211135
- 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
- April 16, 2021
- Decision Date
- January 6, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QEB), ordered by most recent decision date.
Enlight 2100 (TPL-E2103-0)
FDA 510(k)
FDA Class 2
·Anesthesiology
LuMon(TM) System
FDA 510(k)
FDA Class 2
·Anesthesiology
AirTom
FDA 510(k)
FDA Class 2
·Anesthesiology
Enlight 2100
FDA 510(k)
FDA Class 2
·Anesthesiology
Enlight 1810
FDA 510(k)
FDA Class 2
·Anesthesiology