The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Model C386 Isolette(r) Infant Incubator.
| Device ID | K913291 |
| 510k Number | K913291 |
| Device Name: | MODEL C386 ISOLETTE(R) INFANT INCUBATOR |
| Classification | Incubator, Neonatal |
| Applicant | AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-24 |
| Decision Date | 1991-11-13 |