The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for Batter Pack, Replacement For Physio Control Lifepak 500.
| Device ID | K141795 |
| 510k Number | K141795 |
| Device Name: | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | R & D BATTERIES, INC. 2063 WOODBOURNE TERRACE Castle Rock, CO 80104 |
| Contact | Karen Manley |
| Correspondent | Karen Manley R & D BATTERIES, INC. 2063 WOODBOURNE TERRACE Castle Rock, CO 80104 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-03 |
| Decision Date | 2014-12-08 |
| Summary: | summary |