KODAK EKTASCAN LASER PRINTER, MODEL 100
FDA 510(k) clearance K863629 · decided 1986-10-27
Clearance details
- K-number
- K863629
- Device name
- KODAK EKTASCAN LASER PRINTER, MODEL 100
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1986-09-17
- Decision date
- 1986-10-27
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- LMC
- Device class
- 2
- Regulation number
- 892.2040
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.