The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Model Ti500 Isolette Infant Incubator.
| Device ID | K941106 |
| 510k Number | K941106 |
| Device Name: | MODEL TI500 ISOLETTE INFANT INCUBATOR |
| Classification | Incubator, Neonatal Transport |
| 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 | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-07 |
| Decision Date | 1994-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098000413 | K941106 | 000 |
| 04049098000208 | K941106 | 000 |