MODEL #250 DEFIB CABLE
FDA 510(k) clearance K904466 · decided 1991-01-30
Clearance details
- K-number
- K904466
- Device name
- MODEL #250 DEFIB CABLE
- Applicant
- Cardiotronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-01
- Decision date
- 1991-01-30
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.