The following data is part of a premarket notification filed by Stephenson Industries, Inc. with the FDA for Regulator-inhalator System.
| Device ID | K853971 |
| 510k Number | K853971 |
| Device Name: | REGULATOR-INHALATOR SYSTEM |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | STEPHENSON INDUSTRIES, INC. P. O. BOX 1000 Farmingdale, NJ 07727 |
| Contact | Lasley |
| Correspondent | Lasley STEPHENSON INDUSTRIES, INC. P. O. BOX 1000 Farmingdale, NJ 07727 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-26 |
| Decision Date | 1985-12-09 |