The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ribbed Cushion Mask.
| Device ID | K871851 |
| 510k Number | K871851 |
| Device Name: | RIBBED CUSHION MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | ENGINEERED MEDICAL SYSTEMS P.O. BOX 40543 Indianapolis, IN 46240 |
| Contact | Jeff Quinn |
| Correspondent | Jeff Quinn ENGINEERED MEDICAL SYSTEMS P.O. BOX 40543 Indianapolis, IN 46240 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-12 |
| Decision Date | 1987-06-08 |