RTP-5000
FDA 510(k) clearance K813439 · decided 1982-01-22
Clearance details
- K-number
- K813439
- Device name
- RTP-5000
- Applicant
- Adac Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-12-08
- Decision date
- 1982-01-22
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- 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.