CRI ELECTRONIC CONTROL SYSTEM
FDA 510(k) clearance K924125 · decided 1993-05-26
Clearance details
- K-number
- K924125
- Device name
- CRI ELECTRONIC CONTROL SYSTEM
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
- Decision
- Substantially Equivalent
- Date received
- 1992-08-17
- Decision date
- 1993-05-26
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- DXX
- Device class
- 2
- Regulation number
- 870.1290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.