FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App
K Number: K231204
·
Decision Aug 18, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
10
Applicant Total
3
Review Days
113
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Basic Information
- Device Name
- Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App
- K Number
- K231204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3340
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cochlear
- Date Received
- April 27, 2023
- Decision Date
- August 18, 2023
- Product Code
- PFO
- 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 |
|---|---|---|---|
| PFO | Active Implantable Bone Conduction Hearing System | FDA class 2 | Ear, Nose, Throat |
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