Device Classification Name |
indicator, biological sterilization process
|
510(k) Number |
K223715 |
Device Name |
Celerity Incubator |
Applicant |
STERIS Corporation |
5960 Heisley Rd |
Mentor,
OH
44060
|
|
Applicant Contact |
Gregoy Land |
Correspondent |
STERIS Corporation |
5960 Heisley Rd |
Mentor,
OH
44060
|
|
Correspondent Contact |
Gregory Land |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 12/02/2022 |
Decision Date | 06/15/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|