The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Recharge Replace Battery Pk Spacelabs 4045 Mon/defib.
| Device ID | K934015 |
| 510k Number | K934015 |
| Device Name: | RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | PORTABLE POWER SYSTEMS, INC. 10336 SOUTH DRANSFELDT RD. Parker, CO 80134 |
| Contact | Norman A Premo |
| Correspondent | Norman A Premo PORTABLE POWER SYSTEMS, INC. 10336 SOUTH DRANSFELDT RD. Parker, CO 80134 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-17 |
| Decision Date | 1994-02-17 |