ULTRABUR— 510(k) K974174
Substantially EquivalentMednet Locator, Inc.
FDA 510(k) clearance K974174 for ULTRABUR, Substantially Equivalent on 1998-03-10. Applicant: Mednet Locator, Inc.. Device class: 2.
Clearance details
- Applicant
- Mednet Locator, Inc.
- 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
- Memphis, TN, 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.