The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Rescue Mask.
| Device ID | K834250 |
| 510k Number | K834250 |
| Device Name: | RESCUE MASK |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | RONDEX PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-07 |
| Decision Date | 1984-01-18 |