The following data is part of a premarket notification filed by Shanghai 3f Electronics Co Ltd with the FDA for Multi-parameter Patient Monitor, Model# Pms8210a.
| Device ID | K100394 |
| 510k Number | K100394 |
| Device Name: | MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SHANGHAI 3F ELECTRONICS CO LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charles Mack |
| Correspondent | Charles Mack SHANGHAI 3F ELECTRONICS CO LTD 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-04-15 |
| Summary: | summary |