The following data is part of a premarket notification filed by Hill-rom Air-shields with the FDA for Isolette Infant Incubator, Model C2hs.
| Device ID | K001242 |
| 510k Number | K001242 |
| Device Name: | ISOLETTE INFANT INCUBATOR, MODEL C2HS |
| Classification | Incubator, Neonatal |
| Applicant | HILL-ROM AIR-SHIELDS 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | James G Carpenter |
| Correspondent | James G Carpenter HILL-ROM AIR-SHIELDS 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 | 2000-04-18 |
| Decision Date | 2000-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098000345 | K001242 | 000 |
| 04049098000222 | K001242 | 000 |
| 04049098000260 | K001242 | 000 |
| 04049098000277 | K001242 | 000 |
| 04049098000284 | K001242 | 000 |
| 04049098000291 | K001242 | 000 |
| 04049098000307 | K001242 | 000 |
| 04049098000314 | K001242 | 000 |
| 04049098000321 | K001242 | 000 |
| 04049098000338 | K001242 | 000 |
| 04049098000178 | K001242 | 000 |