The following data is part of a premarket notification filed by Rocky Mountain Biosystems, Inc. with the FDA for Biofusionary Bebe.
| Device ID | K121123 |
| 510k Number | K121123 |
| Device Name: | BIOFUSIONARY BEBE |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | ROCKY MOUNTAIN BIOSYSTEMS, INC. 3930 Youngfield Street Wheat Ridge, CO 80033 |
| Contact | Amy Benedict |
| Correspondent | Amy Benedict ROCKY MOUNTAIN BIOSYSTEMS, INC. 3930 Youngfield Street Wheat Ridge, CO 80033 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-13 |
| Decision Date | 2014-03-10 |
| Summary: | summary |