ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)— 510(k) K961073
Substantially EquivalentAtlantis Diagnostics Intl., Inc.
FDA 510(k) clearance K961073 for ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE), Substantially Equivalent on 1997-02-19. Applicant: Atlantis Diagnostics Intl., Inc..
Clearance details
- Applicant
- Atlantis Diagnostics Intl., Inc.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.