EDEMA SYSTEM— 510(k) K962783
Substantially EquivalentBioanalogics, Inc.
FDA 510(k) clearance K962783 for EDEMA SYSTEM, Substantially Equivalent on 1997-10-23. Applicant: Bioanalogics, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioanalogics, Inc.
- 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
- San Diego, CA, US
Recent devices under product code DSB
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