K943011 is an FDA 510(k) clearance for the TUNGSTEN EYESHIELD. This device is classified as a Shield, Eye, Radiological (Class I - General Controls, product code IWS).
Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on December 23, 1994, 182 days after receiving the submission on June 24, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K943011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1994 |
| Decision Date | December 23, 1994 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IWS — Shield, Eye, Radiological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |