The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Golemb Disposable Bag Mask Resuscitator.
| Device ID | K973106 |
| 510k Number | K973106 |
| Device Name: | GOLEMB 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 | 1997-08-19 |
| Decision Date | 1998-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20260720001440 | K973106 | 000 |
| 00026072001431 | K973106 | 000 |
| 00026072001424 | K973106 | 000 |
| 00026072001417 | K973106 | 000 |
| 00026072001325 | K973106 | 000 |
| 00026072001318 | K973106 | 000 |
| 00026072001301 | K973106 | 000 |
| 00026072001295 | K973106 | 000 |
| 00026072001264 | K973106 | 000 |
| 00026072001257 | K973106 | 000 |
| 00026072001240 | K973106 | 000 |
| 00026072001233 | K973106 | 000 |
| 00026072001219 | K973106 | 000 |
| 00026072001196 | K973106 | 000 |
| 00026072001189 | K973106 | 000 |
| 00026072001172 | K973106 | 000 |
| 00026072001448 | K973106 | 000 |
| 20260720001143 | K973106 | 000 |
| 20260720001433 | K973106 | 000 |
| 20260720001426 | K973106 | 000 |
| 20260720001419 | K973106 | 000 |
| 20260720001327 | K973106 | 000 |
| 20260720001310 | K973106 | 000 |
| 20260720001303 | K973106 | 000 |
| 20260720001297 | K973106 | 000 |
| 20260720001266 | K973106 | 000 |
| 20260720001259 | K973106 | 000 |
| 20260720001242 | K973106 | 000 |
| 20260720001235 | K973106 | 000 |
| 20260720001211 | K973106 | 000 |
| 20260720001198 | K973106 | 000 |
| 20260720001181 | K973106 | 000 |
| 20260720001174 | K973106 | 000 |
| 00026072001141 | K973106 | 000 |