The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Emergency Portable Ventilator.
| Device ID | K131098 |
| 510k Number | K131098 |
| Device Name: | EMERGENCY PORTABLE VENTILATOR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St Louis, MO 63110 |
| Contact | Stephen Mundwiller |
| Correspondent | Stephen Mundwiller 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 | 2013-04-18 |
| Decision Date | 2014-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720000081 | K131098 | 000 |
| 00026072000083 | K131098 | 000 |