PET-DOSE
FDA 510(k) clearance K042746 · decided 2004-11-22
Clearance details
- K-number
- K042746
- Device name
- PET-DOSE
- Applicant
- Comecer S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-04
- Decision date
- 2004-11-22
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- KPT
- Device class
- 2
- Regulation number
- 892.1360
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Crofton, MD, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.