K923099 is an FDA 510(k) clearance for the X-RAY DRAPES. This device is classified as a Curtain, Protective, Radiographic (Class I - General Controls, product code IWQ).
Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on October 15, 1992, 112 days after receiving the submission on June 25, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K923099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1992 |
| Decision Date | October 15, 1992 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IWQ — Curtain, Protective, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |