K970154 is an FDA 510(k) clearance for the KODAK EKTASIAN HG FILM (EHG-15). This device is classified as a Film, Radiographic (Class I - General Controls, product code IWZ).
Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on April 4, 1997, 78 days after receiving the submission on January 16, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1840.
| 510(k) Number | K970154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1997 |
| Decision Date | April 04, 1997 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IWZ — Film, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1840 |