Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K232010 |
Device Name |
iTEMPSHIELD |
Applicant |
AION Biosystems Inc. |
12 Plymouth Road |
Darien,
CT
06820
|
|
Applicant Contact |
Joseph Azary |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
Dave Yungvirt |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 07/06/2023 |
Decision Date | 08/04/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|