Proprietary Name: |
989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40 |
Classification Name: |
TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY |
Product Code: |
DRG |
Device Class: |
2 |
Regulation Number: |
870.2910 |
Medical Specialty: |
Cardiovascular |
Registered Establishment Name: |
Philips North America LLC
|
Registered Establishment Number: |
1218950
|
Premarket Submission Number: |
K180017 |
Owner/Operator: |
Philips Medical Systems International BV |
Owner/Operator Number: |
1217116
|
Establishment Operations: |
Specification Developer
|