The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Resuscitation Bag Controller (rbc).
| Device ID | K882278 |
| 510k Number | K882278 |
| Device Name: | RESUSCITATION BAG CONTROLLER (RBC) |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
| Contact | Rose, M.d. |
| Correspondent | Rose, M.d. PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-01 |
| Decision Date | 1988-06-16 |