AposTherapy System
FDA 510(k) clearance K182090 · decided 2018-11-16
Clearance details
- K-number
- K182090
- Device name
- AposTherapy System
- Applicant
- Apos Medical Assets , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-02
- Decision date
- 2018-11-16
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- QDT
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.