The following data is part of a premarket notification filed by Aeros Instruments, Inc. with the FDA for Tote-l-vac.
| Device ID | K932051 |
| 510k Number | K932051 |
| Device Name: | TOTE-L-VAC |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | AEROS INSTRUMENTS, INC. 3411 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Chris Gossett |
| Correspondent | Chris Gossett AEROS INSTRUMENTS, INC. 3411 COMMERCIAL AVE. Northbrook, IL 60062 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1993-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08688250002405 | K932051 | 000 |
| 00628101609320 | K932051 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TOTE-L-VAC 74310693 1863115 Live/Registered |
OHIO MEDICAL CORPORATION 1992-09-02 |