The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Replacement Rechargeable Battery Pack's.
| Device ID | K925449 |
| 510k Number | K925449 |
| Device Name: | REPLACEMENT RECHARGEABLE BATTERY PACK'S |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-28 |
| Decision Date | 1993-04-29 |