FDA Registration Active 🇺🇸 United States

AION BIOSYSTEMS

Reg #: 3028019184 · FEI: 3028019184 · Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1

Registration Details

Registration Name
AION BIOSYSTEMS
Registration Number
3028019184
FEI Number
3028019184
Status
Active
Expiry Year
2026
Initial Importer
No
Address
175 Cabot Street, Suite 100
City
Lowell
State
MA
ZIP
01854
Country
US

Regulatory Submissions

510(k) Number
K250401

Owner / Operator

Firm Name
AION Biosystems
Operator Number
10088613
Address
175 Cabot Street
City
Lowell
State
MA
Postal Code
01854
Country
US
Correspondent
Evi Paloumbis

Products

Device Name Product Code
Continuous Measurement Thermometer FLL

Proprietary Names

AION TempShield™ iTempShield

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility