The following data is part of a premarket notification filed by Aeros Instruments, Inc. with the FDA for Care-e-vac.
Device ID | K926566 |
510k Number | K926566 |
Device Name: | CARE-E-VAC |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | AEROS INSTRUMENTS, INC. 3411 COMMERCIAL AVE. Northbrook, IL 60062 |
Contact | James A Koppa |
Correspondent | James A Koppa AEROS INSTRUMENTS, INC. 3411 COMMERCIAL AVE. Northbrook, IL 60062 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-31 |
Decision Date | 1993-07-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CARE-E-VAC 98756529 not registered Live/Pending |
The ESAB Group, Inc. 2024-09-18 |
![]() CARE-E-VAC 74198716 1752369 Live/Registered |
OHIO MEDICAL CORPORATION 1991-08-26 |