The following data is part of a premarket notification filed by Shanghai 3f Electronics Co Ltd with the FDA for Pms8210a (iris) Multi-parameter Patient Monitor, Model Code 500.
| Device ID | K113183 |
| 510k Number | K113183 |
| Device Name: | PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SHANGHAI 3F ELECTRONICS CO LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charilie Mack |
| Correspondent | Charilie 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-28 |
| Decision Date | 2012-02-09 |
| Summary: | summary |