The following data is part of a premarket notification filed by Pneupac Ltd. with the FDA for Comppac 200hd; Cs12 Power Supply (aircraft/vechile); Ps11 Power Supply (mains).
| Device ID | K040090 |
| 510k Number | K040090 |
| Device Name: | COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | PNEUPAC LTD. N7 W22025 JOHNSON ROAD Waukesha, WI 53186 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander PNEUPAC LTD. N7 W22025 JOHNSON ROAD Waukesha, WI 53186 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-16 |
| Decision Date | 2004-05-27 |
| Summary: | summary |