510(k) K935427

R AND D BATTERIES by R & D Batteries, Inc. — Product Code JAF

K935427 is an FDA 510(k) premarket notification submitted by R & D Batteries, Inc. for the device "R AND D BATTERIES". The FDA issued a decision of Substantially Equivalent on October 21, 1994. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. R & D Batteries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1994
Date Received
November 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type