Mapping Suction Probe— 510(k) K212164
Substantially EquivalentInomed Medizintechnik GmbH
FDA 510(k) clearance K212164 for Mapping Suction Probe, Substantially Equivalent on 2022-11-11. Applicant: Inomed Medizintechnik GmbH. Device class: 2.
Clearance details
- Applicant
- Inomed Medizintechnik GmbH
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Emmendingen, DE
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More clearances from Inomed Medizintechnik GmbH
view allAdverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
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.