ERBEFLO 2 Disposable Tubing System— 510(k) K190469
Substantially EquivalentErbe USA, Inc.
FDA 510(k) clearance K190469 for ERBEFLO 2 Disposable Tubing System, Substantially Equivalent on 2019-05-23. Applicant: Erbe USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Erbe USA, Inc.
- Product code
- Code OCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Recent devices under product code OCX
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view allRecalls naming K190469
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190469.
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