DUMI ManipulatOR
FDA 510(k) clearance K212505 · decided 2022-01-10
Clearance details
- K-number
- K212505
- Device name
- DUMI ManipulatOR
- Applicant
- The O R Company Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-09
- Decision date
- 2022-01-10
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Carrum Downs, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.