510(k) K013133
K013133 is an FDA 510(k) premarket notification submitted by Nordix, Inc. for the device "NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116". The FDA issued a decision of Substantially Equivalent on November 13, 2001. The device falls under product code MOQ (Battery, Replacement, Rechargeable), a Class I device regulated under 21 CFR 878.4820.
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