TCD 100M, PWD13 TRANSDUCER
FDA 510(k) clearance K002533 · decided 2000-08-30
Clearance details
- K-number
- K002533
- Device name
- TCD 100M, PWD13 TRANSDUCER
- Applicant
- Spencer Technologies
- Decision
- Substantially Equivalent
- Date received
- 2000-08-16
- Decision date
- 2000-08-30
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seattle, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcrania recall (Z-0788-04) | Spencer Technologies, Inc. | 2004-07-20 |