The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Ameda Amecare(r) Neonatal Incubator.
| Device ID | K870222 |
| 510k Number | K870222 |
| Device Name: | AMEDA AMECARE(R) NEONATAL INCUBATOR |
| Classification | Incubator, Neonatal |
| Applicant | HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
| Contact | John F Lemker |
| Correspondent | John F Lemker HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-21 |
| Decision Date | 1987-06-10 |