APEX UNIVERSAL DRIVE SYSTEM— 510(k) K964548
Substantially EquivalentLinvatec Corp.
FDA 510(k) clearance K964548 for APEX UNIVERSAL DRIVE SYSTEM, Substantially Equivalent on 1997-01-17. Applicant: Linvatec Corp.. Device class: 2.
Clearance details
- Applicant
- Linvatec Corp.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
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Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.