| Proprietary Name: |
ADF-B05 Wireless Pulse Oximeter; CMS50-Pro Pulse Oximeter; CMS50A Pulse Oximeter; CMS50B Pulse Oximeter; CMS50C Pulse Oximeter; CMS50D Pulse Oximeter; CMS50D+ Pulse Oximeter; CMS50D-BT Pulse Oximeter; CMS50D1-Pro Pulse Oximeter; CMS50D1A Pulse Oximeter; CMS50D2 Pulse Oximeter; CMS50D2-1 Pulse Oximeter; CMS50D2-2 Pulse Oximeter; CMS50D2A Pulse Oximeter; CMS50D4 Pulse Oximeter; CMS50DA Pulse Oximeter; CMS50DA+ Pulse Oximeter; CMS50DA+ TytoCare Pulse Oximeter; CMS50DL Pulse Oximeter; CMS50DL1 Pulse Oximeter; CMS50DL2 Pulse Oximeter; CMS50E Pulse Oximeter; CMS50E-BT Pulse Oximeter; CMS50EA Pulse Oximeter; CMS50EAW Pulse Oximeter; CMS50ED Pulse Oximeter; CMS50EL Pulse Oximeter; CMS50F Pulse Oximeter; CMS50FW Pulse Oximeter; CMS50H Pulse Oximeter; CMS50I Pulse Oximeter; CMS50IW Pulse Oximeter; CMS50K Wearable Monitor; CMS50K1 Wearable Monitor; CMS50L Pulse Oximeter; CMS50L-Pro Pulse Oximeter; CMS50M1 Pulse Oximeter; CMS50N1 Pulse Oximeter; CMS50Q1 Pulse Oximeter; CMS50QA Pulse Oximeter; CMS50QB Pulse Oximeter; CMS50QBA Pulse Oximeter; CMS50S Pulse Oximeter; CMS60 Pulse Oximeter; CMS60C Pulse Oximeter; CMS60CW Pulse Oximeter; CMS60D Pulse Oximeter; CMS60D1 Pulse Oximeter; CMS60DW Pulse Oximeter; CMS60F Pulse Oximeter; CMS60FW Pulse Oximeter; CMS70A Pulse Oximeter; DZ05-A1 Pulse Oximeter; EHP050 Pulse Oximeter; NOSM-6/0700 Oxygen Saturation Monitor; PO20 Pulse Oximeter; UP-200 Pulse Oximeter |
| Classification Name: |
OXIMETER, WELLNESS |
| Product Code: |
PGJ |
| Device Class: |
2 |
| Regulation Number: |
870.2700 |
| Medical Specialty: |
Cardiovascular |
| Registered Establishment Name: |
CONTEC MEDICAL SYSTEMS CO., LTD
|
| Registered Establishment Number: |
3006979678
|
| Owner/Operator: |
CONTEC MEDICAL SYSTEMS CO., LTD |
| Owner/Operator Number: |
10025156
|
| Establishment Operations: |
Manufacturer
|
