CARDIOVIT AT-102 G2— 510(k) K183425
Substantially EquivalentSchiller AG
FDA 510(k) clearance K183425 for CARDIOVIT AT-102 G2, Substantially Equivalent on 2020-03-02. Applicant: Schiller AG. Device class: 2.
Clearance details
- Applicant
- Schiller AG
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baar, CH
Recent devices under product code DPS
view allMore clearances from Schiller AG
view allAdverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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 →
Recalls naming K183425
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183425.
Data sourced from openFDA. This site is unofficial and independent of the FDA.