K052171 is an FDA 510(k) clearance for the ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on October 13, 2005, 65 days after receiving the submission on August 9, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K052171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2005 |
| Decision Date | October 13, 2005 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |