BIOFLOW— 510(k) K831422
Substantially EquivalentBomed Medical Mfr., Ltd.
FDA 510(k) clearance K831422 for BIOFLOW, Substantially Equivalent on 1983-09-12. Applicant: Bomed Medical Mfr., Ltd.. Device class: 2.
Clearance details
- Applicant
- Bomed Medical Mfr., Ltd.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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