EXPLORER CVS TRANSCRANIAL DOPPLER
FDA 510(k) clearance K990517 · decided 2000-08-01
Clearance details
- K-number
- K990517
- Device name
- EXPLORER CVS TRANSCRANIAL DOPPLER
- Applicant
- Diagnostic Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-02-18
- Decision date
- 2000-08-01
- Days to decision
- 530 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- La Jolla, CA, US
- Third-party review
- No
- 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| UBIS 5000 BONE SONOMETER (P000055) | Diagnostic Medical Systems | 2001-07-17 |