The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Pmx Disposable Bag Mask Resuscitator.
| Device ID | K014071 |
| 510k Number | K014071 |
| Device Name: | PMX DISPOSABLE BAG MASK RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Contact | Vernon Trimble |
| Correspondent | Vernon Trimble ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40260720000249 | K014071 | 000 |
| 00026072000236 | K014071 | 000 |
| 00026072000243 | K014071 | 000 |
| 00026072000199 | K014071 | 000 |
| 00026072000205 | K014071 | 000 |
| 00026072000212 | K014071 | 000 |
| 40260720000195 | K014071 | 000 |
| 40260720000201 | K014071 | 000 |
| 40260720000218 | K014071 | 000 |
| 40260720000225 | K014071 | 000 |
| 40260720000232 | K014071 | 000 |
| 00026072000229 | K014071 | 000 |