HS AMICA— 510(k) K083157
Substantially EquivalentH.S Hospital Service S.P.A
FDA 510(k) clearance K083157 for HS AMICA, Substantially Equivalent on 2009-09-29. Applicant: H.S Hospital Service S.P.A. Device class: 2.
Clearance details
- Applicant
- H.S Hospital Service S.P.A
- Product code
- Code NEY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
Recent devices under product code NEY
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- K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS)
- K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)
- K241825 — Microwave Ablation Antennas
More clearances from H.S Hospital Service S.P.A
view allAdverse events under product code NEY
product code NEY- Death
- 24
- Injury
- 388
- Malfunction
- 462
- Other
- 1
- Total
- 875
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.