K022248 is an FDA 510(k) clearance for the STRYKER L3 HYDROLERT. This device is classified as a Monitor, Electric For Gravity Flow Infusion Systems (Class II - Special Controls, product code FLN).
Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on August 6, 2002, 25 days after receiving the submission on July 12, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2420.
| 510(k) Number | K022248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2002 |
| Decision Date | August 06, 2002 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLN — Monitor, Electric For Gravity Flow Infusion Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2420 |