The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Infant Disposable Bag Mask Resuscitator.
| Device ID | K922819 |
| 510k Number | K922819 |
| Device Name: | INFANT DISPOSABLE BAG MASK RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Contact | Vernon Trimble |
| Correspondent | Vernon Trimble LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-11 |
| Decision Date | 1993-11-24 |