The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Resuscitaire.
| Device ID | K830748 |
| 510k Number | K830748 |
| Device Name: | RESUSCITAIRE |
| Classification | Warmer, Infant Radiant |
| Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-09 |
| Decision Date | 1983-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RESUSCITAIRE 74309725 1981321 Live/Registered |
DRAEGER MEDICAL SYSTEMS, INC. 1992-09-01 |
![]() RESUSCITAIRE 73569454 1407570 Dead/Cancelled |
VICKERS PLC 1985-11-20 |