K190306 is an FDA 510(k) clearance for the AMD Ritmed AssureWear VersaGown. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Amd Medicom, Inc. (Pointe-Claire, Montreal, CA). The FDA issued a Cleared decision on January 17, 2020, 339 days after receiving the submission on February 12, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K190306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2019 |
| Decision Date | January 17, 2020 |
| Days to Decision | 339 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYC — Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |