ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.— 510(k) K893476
Substantially EquivalentAndros Analyzers, Inc.
FDA 510(k) clearance K893476 for ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV., Substantially Equivalent on 1989-06-23. Applicant: Andros Analyzers, Inc.. Device class: 2.
Clearance details
- Applicant
- Andros Analyzers, Inc.
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkeley, CA, US
Recent devices under product code JAA
view allMore clearances from Andros Analyzers, Inc.
view allAdverse events under product code JAA
product code JAA- 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.