The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Intellicuff.
Device ID | K150893 |
510k Number | K150893 |
Device Name: | IntelliCuff |
Classification | Cuff, Tracheal Tube, Inflatable |
Applicant | HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH 7402 |
Contact | Steffen Boden |
Correspondent | Steffen Boden HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH 7402 |
Product Code | BSK |
CFR Regulation Number | 868.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-02 |
Decision Date | 2016-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630002800839 | K150893 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTELLICUFF 87883656 5631694 Live/Registered |
HAMILTON Medical AG 2018-04-19 |
INTELLICUFF 79094166 4123566 Live/Registered |
HAMILTON Medical AG 2011-02-04 |
INTELLICUFF 76664091 3313220 Dead/Cancelled |
iSECURETrac Inc. 2006-08-03 |