Proprietary Name: |
Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA) |
Classification Name: |
TRANSDUCER, PRESSURE, INTRAUTERINE |
Product Code: |
HFN |
Device Class: |
2 |
Regulation Number: |
884.2700 |
Medical Specialty: |
Obstetrics/Gynecology |
Registered Establishment Name: |
Philips North America LLC
|
Registered Establishment Number: |
1218950
|
Premarket Submission Number: |
K140535 |
Owner/Operator: |
Philips Medical Systems International BV |
Owner/Operator Number: |
1217116
|
Establishment Operations: |
Specification Developer
|
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