The following data is part of a premarket notification filed by Rantran, Inc. with the FDA for Betamist 2.
| Device ID | K923698 |
| 510k Number | K923698 |
| Device Name: | BETAMIST 2 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
| Contact | Ed Ransom |
| Correspondent | Ed Ransom RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-24 |
| Decision Date | 1993-02-18 |