The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Bariair.
Device ID | K955243 |
510k Number | K955243 |
Device Name: | BARIAIR |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78216 -9508 |
Contact | William H Quirk |
Correspondent | William H Quirk KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78216 -9508 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-15 |
Decision Date | 1997-10-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BARIAIR 75314322 2224795 Live/Registered |
HUNTLEIGH TECHNOLOGY LTD. 1997-06-24 |