JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
FDA 510(k) clearance K963334 · decided 1996-09-11
Clearance details
- K-number
- K963334
- Device name
- JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
- Applicant
- Jamieson Film Co.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-26
- Decision date
- 1996-09-11
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- IXX
- Device class
- 2
- Regulation number
- 892.1900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AP-6CR CINERADIOGRAPHIC FILM PROCESSOR (K915365) | The Allen Products Co. | 1992-08-27 |
| JAMIESON JT-CRP CINE FILM PROCESSOR (K913241) | Jamieson Film Co. | 1991-09-24 |
| STERILE O. R. TOWEL (K861928) | Anago, Inc. | 1986-06-09 |
| CINE RADIOGRAPHIC FILM PROCESSOR M-45CR (K850421) | The Allen Products Co. | 1985-03-22 |
| RADIOGRAPHIC FILM PROCESSOR M-30CR & (K841431) | The Allen Products Co. | 1984-07-06 |
Recalls involving this device
No recalls on record reference this clearance.