K101940 is an FDA 510(k) clearance for the EQUASHIELD SYSTEM PROTECTIVE PLUS. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Equashield Medical , Ltd. (Migdal, IL). The FDA issued a Cleared decision on November 19, 2010, 130 days after receiving the submission on July 12, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K101940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2010 |
| Decision Date | November 19, 2010 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |