Submission Details
| 510(k) Number | K133870 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2013 |
| Decision Date | April 24, 2014 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
FLUID LEVEL MONITOR
Apr 2014
Decision
125d
Days
Class 2
Risk
About This 510(k) Submission
K133870 is an FDA 510(k) clearance for the FLUID LEVEL MONITOR, a Monitor, Electric For Gravity Flow Infusion Systems (Class II — Special Controls, product code FLN), submitted by Coleman Laboratories (King Of Prussia, US). The FDA issued a Cleared decision on April 24, 2014, 125 days after receiving the submission on December 20, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2420.
Device Classification
| Product Code | FLN — Monitor, Electric For Gravity Flow Infusion Systems |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2420 |
Manufacturer
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