The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Engstrom Metabolic Computer.
| Device ID | K821344 |
| 510k Number | K821344 |
| Device Name: | ENGSTROM METABOLIC COMPUTER |
| Classification | Computer, Oxygen-uptake |
| Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-05 |
| Decision Date | 1982-05-28 |