NAMIC ARIA(TM) INFLATION DEVICE— 510(k) K940542
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K940542 for NAMIC ARIA(TM) INFLATION DEVICE, Substantially Equivalent on 1994-04-18. Applicant: American Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code EZN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5470
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
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More clearances from American Medical Systems, Inc.
view allAdverse events under product code EZN
product code EZN- Death
- 3
- Injury
- 127
- Total
- 130
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.