ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES— 510(k) K900176
Substantially EquivalentMachida, Inc.
FDA 510(k) clearance K900176 for ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES, Substantially Equivalent on 1990-04-10. Applicant: Machida, Inc.. Device class: 2.
Clearance details
- Applicant
- Machida, Inc.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
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Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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.