Proprietary Name: |
21075A Esophageal/Rectal 12 Fr Temperature Probe; 21076A Esophageal/Rectal 10 Fr Temperature Probe; 21078A Skin Surface Temperature Probe; 989803203561 Esophageal/Rectal Temperature Probe 12 Fr, Reusable, Autoclavable; 989803203571 Esophageal/Rectal Temperature Probe 10 Fr, Reusable, Autoclavable; 989803203581 Skin Temperature Probe, Reusable, Autoclavable |
Classification Name: |
THERMOMETER, ELECTRONIC, CLINICAL |
Product Code: |
FLL |
Device Class: |
2 |
Regulation Number: |
880.2910 |
Medical Specialty: |
General Hospital |
Registered Establishment Name: |
Philips North America LLC
|
Registered Establishment Number: |
1218950
|
Premarket Submission Number: |
K962070 |
Owner/Operator: |
Philips Medical Systems International BV |
Owner/Operator Number: |
1217116
|
Establishment Operations: |
Repackager/Relabeler
|