Model 206 Electrometer/Dosimeter
FDA 510(k) clearance K150265 · decided 2015-09-03
Clearance details
- K-number
- K150265
- Device name
- Model 206 Electrometer/Dosimeter
- Applicant
- Cnmc Company Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2015-02-04
- Decision date
- 2015-09-03
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Nashville, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.