FSC 2— 510(k) K090601
Substantially EquivalentSchoelly Imaging, Inc.
FDA 510(k) clearance K090601 for FSC 2, Substantially Equivalent on 2009-05-11. Applicant: Schoelly Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Schoelly Imaging, Inc.
- Product code
- Code NTN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Boylston, MA, US
Recent devices under product code NTN
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view allAdverse events under product code NTN
product code NTN- Other
- 1
- Total
- 1
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 →
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