510(k) K935244
K935244 is an FDA 510(k) premarket notification submitted by R & D Batteries, Inc. for the device "R & D BATTERIES, INC. PART NUMBER 5113". The FDA issued a decision of Substantially Equivalent on April 19, 1994. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. R & D Batteries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1994
- Date Received
- November 1, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Communication, Powered
- Device Class
- Class II
- Regulation Number
- 890.3710
- Review Panel
- PM
- Submission Type