Rhinolaryngoscope system— 510(k) K232435
Substantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.
FDA 510(k) clearance K232435 for Rhinolaryngoscope system, Substantially Equivalent on 2024-04-26. Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd..
Clearance details
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Product code
- Code EOB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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.