FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
FDA 510(k) clearance K042039 · decided 2004-11-17
Clearance details
- K-number
- K042039
- Device name
- FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
- Applicant
- Cleveland Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-29
- Decision date
- 2004-11-17
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.