K973115 is an FDA 510(k) clearance for the ARRIPRO 35 ST/TV. This device is classified as a Illuminator, Radiographic-film (Class I - General Controls, product code IXC).
Submitted by Arnold & Richter Cine Technik (Munich, DE). The FDA issued a Cleared decision on September 2, 1997, 13 days after receiving the submission on August 20, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1890.
| 510(k) Number | K973115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1997 |
| Decision Date | September 02, 1997 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXC — Illuminator, Radiographic-film |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1890 |