The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Physio Control Lifepak 200 Auto Defibrillator.
| Device ID | K946080 |
| 510k Number | K946080 |
| Device Name: | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR |
| Classification | Box, Battery, Rechargeable |
| Applicant | PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
| Contact | Norman A Premop |
| Correspondent | Norman A Premop PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
| Product Code | FCO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-08-02 |