MODEL 6110C OTOPHOR— 510(k) K870272
Substantially EquivalentLife-Tech Intl., Inc.
FDA 510(k) clearance K870272 for MODEL 6110C OTOPHOR, Substantially Equivalent on 1987-08-05. Applicant: Life-Tech Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Life-Tech Intl., Inc.
- 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
- Houston, TX, US
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More clearances from Life-Tech Intl., Inc.
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.