DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
FDA 510(k) clearance K962613 · decided 1996-09-27
Clearance details
- K-number
- K962613
- Device name
- DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
- Applicant
- Gulmay Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-03
- Decision date
- 1996-09-27
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shepperton, Middlesex, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.