CEMAX-1000
FDA 510(k) clearance K833525 · decided 1983-11-21
Clearance details
- K-number
- K833525
- Device name
- CEMAX-1000
- Applicant
- Contour Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-22
- Decision date
- 1983-11-21
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.