Single-Use Video Bronchoscopes, Digital Controller
FDA 510(k) clearance K213782 · decided 2022-07-08
Clearance details
- K-number
- K213782
- Device name
- Single-Use Video Bronchoscopes, Digital Controller
- Applicant
- Micro-Tech (Nanjing) Co., Lts
- Decision
- Substantially Equivalent
- Date received
- 2021-12-03
- Decision date
- 2022-07-08
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Nanjing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.