FDA Registration Active 🇺🇸 United States

Pulsewave Health Monitor

Reg #: 3010984687 · FEI: 3010984687 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1

Registration Details

Registration Name
Cloud DX Inc.
Registration Number
3010984687
FEI Number
3010984687
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
#824 - 20 JAY STREET
City
Brooklyn
State
NY
ZIP
11201
Country
US

Regulatory Submissions

510(k) Number
K122443

Owner / Operator

Firm Name
CloudDX Inc.
Operator Number
10048345
Address
20 Jay St, Suite 834
City
Brooklyn
State
NY
Postal Code
11201
Country
US

Products

Device Name Product Code
System, Measurement, Blood-Pressure, Non-Invasive DXN

Proprietary Names

Pulsewave Health Monitor PAD-1A

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device