510(k) K013133
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2001
- Date Received
- September 19, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Battery, Replacement, Rechargeable
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type