The following data is part of a premarket notification filed by Coleman Laboratories with the FDA for Fluid Level Monitor.
| Device ID | K133870 |
| 510k Number | K133870 |
| Device Name: | FLUID LEVEL MONITOR |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | COLEMAN LABORATORIES 1150 FIRST AVENUE, SUITE 501 King Of Prussia, PA 19406 |
| Contact | Le-jun Yin |
| Correspondent | Le-jun Yin COLEMAN LABORATORIES 1150 FIRST AVENUE, SUITE 501 King Of Prussia, PA 19406 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-04-24 |
| Summary: | summary |