The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracoe Smart Cuff Manager.
Device ID | K152865 |
510k Number | K152865 |
Device Name: | TRACOE Smart Cuff Manager |
Classification | Cuff, Tracheal Tube, Inflatable |
Applicant | TRACOE MEDICAL GMBH REICHELSHEIMER STR. 1/3 Nieder-olm, DE D-55268 |
Contact | Stephan Kohler |
Correspondent | Eva Schaeffer TRACOE MEDICAL GMBH REICHELSHEIMER STR. 1/3 55268 Nieder-olm, DE D-55268 |
Product Code | BSK |
CFR Regulation Number | 868.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-30 |
Decision Date | 2016-09-27 |
Summary: | summary |