The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Engstrom Emma Anesthetic Gas Monitor.
| Device ID | K802614 |
| 510k Number | K802614 |
| Device Name: | ENGSTROM EMMA ANESTHETIC GAS MONITOR |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-21 |
| Decision Date | 1981-01-07 |