K173531 is an FDA 510(k) clearance for the Lockbox for Perfusor Space PCA Infusion Pump. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on August 2, 2018, 260 days after receiving the submission on November 15, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K173531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2017 |
| Decision Date | August 02, 2018 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MRZ — Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |