OLYMPUS BF TYPE UM40
FDA 510(k) clearance K021204 · decided 2002-05-01
Clearance details
- K-number
- K021204
- Device name
- OLYMPUS BF TYPE UM40
- Applicant
- Olympus Optical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-16
- Decision date
- 2002-05-01
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- PSV
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Melville, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (K183525) | Olympus Medical Systems Corp. | 2019-09-06 |
| OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM (K070983) | Olympus Medical Systems Corporation | 2007-07-05 |
Recalls involving this device
No recalls on record reference this clearance.