QUANTIX/OR DEVICE
FDA 510(k) clearance K030357 · decided 2003-08-20
Clearance details
- K-number
- K030357
- Device name
- QUANTIX/OR DEVICE
- Applicant
- Cardiosonix, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-03
- Decision date
- 2003-08-20
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kfar Saba, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system. recall (Z-0700-05) | Neoprobe Corp | 2005-04-13 |
| Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system. recall (Z-0701-05) | Neoprobe Corp | 2005-04-13 |