The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Imv System.
| Device ID | K780340 |
| 510k Number | K780340 |
| Device Name: | IMV SYSTEM |
| Classification | Bottle, Collection, Breathing System (calibrated) |
| Applicant | LKB INSTRUMENTS, INC. KS |
| Product Code | CBD |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-01 |
| Decision Date | 1978-11-27 |