The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Battery Pack #pmx120-18a.
| Device ID | K945043 |
| 510k Number | K945043 |
| Device Name: | BATTERY PACK #PMX120-18A |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1995-01-20 |