The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Triadyne.
Device ID | K944094 |
510k Number | K944094 |
Device Name: | TRIADYNE |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Contact | William H Quirk |
Correspondent | William H Quirk KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-22 |
Decision Date | 1995-05-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRIADYNE 74629832 2046417 Live/Registered |
HUNTLEIGH TECHNOLOGY LTD. 1995-02-03 |