The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Parapac 200d Transport, Model V200d.
| Device ID | K030803 |
| 510k Number | K030803 |
| Device Name: | PARAPAC 200D TRANSPORT, MODEL V200D |
| 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 | 2003-03-13 |
| Decision Date | 2003-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517062209 | K030803 | 000 |
| 35019517062179 | K030803 | 000 |
| 35019517053849 | K030803 | 000 |
| 35019315074183 | K030803 | 000 |
| 30610586045558 | K030803 | 000 |