The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Engstom Edith.
| Device ID | K821365 |
| 510k Number | K821365 |
| Device Name: | ENGSTOM EDITH |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-07 |
| Decision Date | 1982-06-29 |