DORO QR3 XTom Headholder System— 510(k) K191979
Substantially EquivalentPro Med Instruments GmbH
FDA 510(k) clearance K191979 for DORO QR3 XTom Headholder System, Substantially Equivalent on 2019-10-22. Applicant: Pro Med Instruments GmbH. Device class: 2.
Clearance details
- Applicant
- Pro Med Instruments GmbH
- Product code
- Code HBL
- Device class
- Class 2
- Regulation
- 21 CFR 882.4460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, DE
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More clearances from Pro Med Instruments GmbH
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Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
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.