The following data is part of a premarket notification filed by Hill-rom Air-shields with the FDA for Versalet 7700 Care Center, Model # 7700.
| Device ID | K993051 |
| 510k Number | K993051 |
| Device Name: | VERSALET 7700 CARE CENTER, MODEL # 7700 |
| 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 | 1999-09-13 |
| Decision Date | 2000-02-03 |
| Summary: | summary |