The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Comppac Ventilator Models 200 & Ps11 Power Supply/charger.
| Device ID | K021841 |
| 510k Number | K021841 |
| Device Name: | COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | PNEU PAC, LTD. SMITHS MEDICAL N7 W22025 JOHNSON ROAD Waukesha, WI 53186 -1856 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander PNEU PAC, LTD. SMITHS MEDICAL N7 W22025 JOHNSON ROAD Waukesha, WI 53186 -1856 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-05 |
| Decision Date | 2003-07-17 |
| Summary: | summary |