The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Emergency Portable Ventilator, Model Epv200.
| Device ID | K090356 |
| 510k Number | K090356 |
| Device Name: | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Contact | Wayne Karcher |
| Correspondent | Wayne Karcher ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-12 |
| Decision Date | 2009-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720000319 | K090356 | 000 |
| 00026072000274 | K090356 | 000 |
| 00026072000281 | K090356 | 000 |
| 00026072000304 | K090356 | 000 |
| 00026072000311 | K090356 | 000 |
| 00260720000265 | K090356 | 000 |
| 00260720000272 | K090356 | 000 |
| 00260720000289 | K090356 | 000 |
| 00260720000302 | K090356 | 000 |
| 00026072000267 | K090356 | 000 |