ONEFLOW— 510(k) K980951
Substantially EquivalentSti Medical
FDA 510(k) clearance K980951 for ONEFLOW, Substantially Equivalent on 2000-02-25. Applicant: Sti Medical. Device class: 2.
Clearance details
- Applicant
- Sti Medical
- Product code
- Code BZH
- Device class
- Class 2
- Regulation
- 21 CFR 868.1860
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cedar Grove, NJ, US
Recent devices under product code BZH
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