The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Ahp 300, Emergency Portable Ventilator.
| Device ID | K132021 |
| 510k Number | K132021 |
| Device Name: | AHP 300, EMERGENCY PORTABLE VENTILATOR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. Saint Louis, MO 63110 |
| Contact | Stephen Mundwiller |
| Correspondent | Stephen Mundwiller ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. Saint 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 | 2013-07-02 |
| Decision Date | 2014-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720000173 | K132021 | 000 |
| 00026072000021 | K132021 | 000 |
| 00026072000038 | K132021 | 000 |
| 00026072000045 | K132021 | 000 |
| 00026072000052 | K132021 | 000 |
| 00026072000069 | K132021 | 000 |
| 00026072000076 | K132021 | 000 |
| 00026072000168 | K132021 | 000 |
| 00026072000175 | K132021 | 000 |
| 00260720000029 | K132021 | 000 |
| 00260720000036 | K132021 | 000 |
| 00260720000043 | K132021 | 000 |
| 00260720000050 | K132021 | 000 |
| 00260720000067 | K132021 | 000 |
| 00260720000074 | K132021 | 000 |
| 00260720000166 | K132021 | 000 |
| 00026072000014 | K132021 | 000 |