MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06
FDA 510(k) clearance K860761 · decided 1986-04-01
Clearance details
- K-number
- K860761
- Device name
- MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06
- Applicant
- Lenzar Optics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-28
- Decision date
- 1986-04-01
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- LMC
- Device class
- 2
- Regulation number
- 892.2040
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Riviera Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.