RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM— 510(k) K141809
Substantially EquivalentDefibtech, LLC
FDA 510(k) clearance K141809 for RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM, Substantially Equivalent on 2014-10-27. 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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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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.