The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Lbi-100 37degrees Incubator.
| Device ID | K830405 |
| 510k Number | K830405 |
| Device Name: | LBI-100 37DEGREES INCUBATOR |
| Classification | Bath, Incubators/water, All |
| Applicant | BIONETIC LABORATORY PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTQ |
| CFR Regulation Number | 866.2540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-07 |
| Decision Date | 1983-03-10 |