EG-3830UT
FDA 510(k) clearance K041397 · decided 2004-06-09
Clearance details
- K-number
- K041397
- Device name
- EG-3830UT
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-26
- Decision date
- 2004-06-09
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Orangeburg, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ul recall (Z-2116-2014) | Pentax Medical Company | 2014-07-24 |