510(k) K121123
K121123 is an FDA 510(k) premarket notification submitted by Rocky Mountain Biosystems, Inc. for the device "BIOFUSIONARY BEBE". The FDA issued a decision of Substantially Equivalent on March 10, 2014. The device falls under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2014
- Date Received
- April 13, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5290
- Review Panel
- PM
- Submission Type