RMU-2000 Automated Chest Compression System— 510(k) K211289
Substantially EquivalentDefibtech, LLC
FDA 510(k) clearance K211289 for RMU-2000 Automated Chest Compression System, Substantially Equivalent on 2021-11-09. Applicant: Defibtech, LLC. Device class: 2.
Clearance details
- Applicant
- Defibtech, LLC
- Product code
- Code DRM
- Device class
- Class 2
- Regulation
- 21 CFR 870.5200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guilford, CT, US
Recent devices under product code DRM
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- K033896 — DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
Adverse events under product code DRM
product code DRM- Death
- 82
- Injury
- 126
- Malfunction
- 4,539
- Total
- 4,747
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 K211289
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 K211289.
Data sourced from openFDA. This site is unofficial and independent of the FDA.