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 |