K931604 is an FDA 510(k) clearance for the 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE. This device is classified as a Film, Radiographic (Class I - General Controls, product code IWZ).
Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on July 21, 1993, 111 days after receiving the submission on April 1, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1840.
| 510(k) Number | K931604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1993 |
| Decision Date | July 21, 1993 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWZ — Film, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1840 |