The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Replacement Batter For Abbott Labs Lifecare 4100 S.
| Device ID | K931484 |
| 510k Number | K931484 |
| Device Name: | REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-24 |
| Decision Date | 1994-02-17 |