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 |