The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Battery Pack 1017la.
| Device ID | K931716 |
| 510k Number | K931716 |
| Device Name: | BATTERY PACK 1017LA |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
| Contact | Norman A Premo |
| Correspondent | Norman A Premo PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-06 |
| Decision Date | 1994-02-07 |