BX-200 SC— 510(k) K943185
Substantially Equivalent for Some IndicationsBloomex International, Inc.
FDA 510(k) clearance K943185 for BX-200 SC, Substantially Equivalent for Some Indications on 1995-08-14. Applicant: Bloomex International, Inc.. Device class: 2.
Clearance details
- Applicant
- Bloomex International, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Elmwood Park, NJ, US
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