FDA Registration Active 🇮🇱 Israel

WatchPAT200U Central+

Reg #: 3017638059 · FEI: 3017638059 · Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Itamar Medical Ltd. (Alon)
Registration Number
3017638059
FEI Number
3017638059
Status
Active
Expiry Year
2025
Initial Importer
No
Address
11 Alon HaTavor St, South Industrial Park
City
Caesarea Haifa
Country
IL

Regulatory Submissions

510(k) Number
K161579

Owner / Operator

Firm Name
ITAMAR MEDICAL INC
Operator Number
9041901
Address
3290 Cumberland Club Drive, Suite 100
City
Atlanta
State
GA
Postal Code
30339
Country
US

Products

Device Name Product Code
Ventilatory Effort Recorder MNR

Proprietary Names

WatchPAT200U Central+ CentralPlus sensor SBP sensor Watch-PAT200U (WP200U) WatchPAT Central+ WatchPAT Central+ kit RESBP sensor WP200U Central+ Central+ sensor WatchPAT UnifiedPAT Probe

Establishment Types

Manufacture Medical Device