The following data is part of a premarket notification filed by Boekel Industries, Inc. with the FDA for Blood Gas Incubator #260650.
| Device ID | K823766 |
| 510k Number | K823766 |
| Device Name: | BLOOD GAS INCUBATOR #260650 |
| Classification | Block, Heating |
| Applicant | BOEKEL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JRG |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1983-02-18 |