BIOFUSIONARY BEBE— 510(k) K121123
Substantially EquivalentRocky Mountain Biosystems, Inc.
FDA 510(k) clearance K121123 for BIOFUSIONARY BEBE, Substantially Equivalent on 2014-03-10. Applicant: Rocky Mountain Biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Rocky Mountain Biosystems, Inc.
- Product code
- Code IMJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5290
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheat Ridge, CO, US
Recent devices under product code IMJ
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