MICRO-MAX, MODEL 319
Device Facts
| Record ID | K002404 |
|---|---|
| Device Name | MICRO-MAX, MODEL 319 |
| Applicant | Tek Marketing, Inc. |
| Product Code | IXW · Radiology |
| Decision Date | Aug 30, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
