EB-1830T3, VIDEO BRONCHOSCOPE
FDA 510(k) clearance K023376 · decided 2002-10-16
Clearance details
- K-number
- K023376
- Device name
- EB-1830T3, VIDEO BRONCHOSCOPE
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-08
- Decision date
- 2002-10-16
- Days to decision
- 8 days
- Clearance type
- Special
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bronchoscope Intended to provide optical visualization of and therapeutic access to the Ai recall (Z-2065-2016) | Pentax Medical Company | 2016-06-28 |
| Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualiza recall (Z-2076-2016) | Pentax Medical Company | 2016-06-28 |
| EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical visualiza recall (Z-0818-2012) | Pentax Medical Company | 2012-01-20 |