AUTOMATIC FILM PROCESSORIO M. R80
FDA 510(k) clearance K781068 · decided 1978-07-17
Clearance details
- K-number
- K781068
- Device name
- AUTOMATIC FILM PROCESSORIO M. R80
- Applicant
- Tecnomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-26
- Decision date
- 1978-07-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- IWX
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| A2J MZ 45 LASER LIGHT FOR POSITIONING (K881591) | A2j, Inc. | 1988-04-27 |
| MOBILE LEAD PLASTIC X-RAY BARRIERS (K850813) | Victoreen, Inc. | 1985-04-10 |
Recalls involving this device
No recalls on record reference this clearance.