ULTRASOUND SCANNER, TYPE 2400
FDA 510(k) clearance K024236 · decided 2003-01-17
Clearance details
- K-number
- K024236
- Device name
- ULTRASOUND SCANNER, TYPE 2400
- Applicant
- B-K Medical A/S
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2003-01-17
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Herlev, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Med recall (Z-1140-2008) | B & K Medical Systems, Inc. | 2008-06-10 |
| Linear Array Transducer Type: 8809 recall (Z-0271-05) | B & K Medical Systems Inc. | 2004-12-02 |