K972849 is an FDA 510(k) clearance for the ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on May 28, 1998, 300 days after receiving the submission on August 1, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K972849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1997 |
| Decision Date | May 28, 1998 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |