FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Jabra Enhance Plus
K Number: K213424
·
Decision Jan 19, 2022
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
6
Applicant Total
4
Review Days
90
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
- Jabra Enhance Plus
- K Number
- K213424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3325
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GN Hearing A/S
- Date Received
- October 21, 2021
- Decision Date
- January 19, 2022
- Product Code
- QDD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QDD), ordered by most recent decision date.
Lumen 155-SF
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Vibe SF Self-Fitting Hearing Aid
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MDHearingAid app, MDHearingAid Smart hearing aids
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BHA100 Series Braun Clear Hearing Aid
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bose SoundControl Hearing Aids
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bose Hearing Aid
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat