The following data is part of a premarket notification filed by Draeger Medical Infant Care, Inc. with the FDA for Versalet 7700 Care Center.
| Device ID | K053399 |
| 510k Number | K053399 |
| Device Name: | VERSALET 7700 CARE CENTER |
| Classification | Incubator, Neonatal |
| Applicant | DRAEGER MEDICAL INFANT CARE, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante DRAEGER MEDICAL INFANT CARE, 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 | 2005-12-06 |
| Decision Date | 2006-08-04 |
| Summary: | summary |