510(k) K221195
- Device
- OsteoProbe
- Applicant
- Active Life Scientific, Inc.
- 510(k) number
- K221195
- Product code
- QGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-28
- Date received
- 2022-04-25
- Regulation
- 888.1600
- Classification name
- Bone Indentation Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alexander Proctor
- Address
- 1027 Garden St. Santa Barbara CA US 93101 93101
FDA Registration Numbers#
- 2027062
- 3014894280