The following data is part of a premarket notification filed by Aeros Instruments, Inc. with the FDA for Instavac Ii.
| Device ID | K934976 |
| 510k Number | K934976 |
| Device Name: | INSTAVAC II |
| 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 | 1993-10-19 |
| Decision Date | 1994-05-02 |