The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Autovent Model 4000.
| Device ID | K070120 |
| 510k Number | K070120 |
| Device Name: | AUTOVENT MODEL 4000 |
| 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 | 2007-01-12 |
| Decision Date | 2007-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00360720001385 | K070120 | 000 |
| 00260720001408 | K070120 | 000 |
| 00260720001361 | K070120 | 000 |
| 00260720001347 | K070120 | 000 |
| 00026072001400 | K070120 | 000 |
| 00026072001363 | K070120 | 000 |
| 00026072001349 | K070120 | 000 |
| 00026072001387 | K070120 | 000 |