The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Isolette Incubator.
| Device ID | K781876 |
| 510k Number | K781876 |
| Device Name: | ISOLETTE INCUBATOR |
| Classification | Incubator, Neonatal |
| Applicant | AIR-SHIELDS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-02 |
| Decision Date | 1978-12-07 |