AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS— 510(k) K093773
Substantially EquivalentAmsino International, Inc.
FDA 510(k) clearance K093773 for AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS, Substantially Equivalent on 2010-03-10. Applicant: Amsino International, Inc.. Device class: 2.
Clearance details
- Applicant
- Amsino International, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pomona, CA, US
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- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Amsino International, Inc.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.