EmBody System
FDA 510(k) clearance K183450 · decided 2019-06-20
Clearance details
- K-number
- K183450
- Device name
- EmBody System
- Applicant
- Inmode MD , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-12
- Decision date
- 2019-06-20
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- PBX
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.