CATCH AND HOLD OPTION FOR INSTASCAN— 510(k) K934514
Substantially EquivalentAdvanced Nmr Systems, Inc.
FDA 510(k) clearance K934514 for CATCH AND HOLD OPTION FOR INSTASCAN, Substantially Equivalent on 1994-06-21. Applicant: Advanced Nmr Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Nmr Systems, Inc.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, MA, US
Recent devices under product code LNH
view allMore clearances from Advanced Nmr Systems, Inc.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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.