The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Cuff Inflator (vci).
Device ID | K173914 |
510k Number | K173914 |
Device Name: | VORTRAN Cuff Inflator (VCI) |
Classification | Cuff, Tracheal Tube, Inflatable |
Applicant | VORTRAN Medical Technology 1, Inc. 21 Goldenland Court #100 Sacramento, CA 95834 |
Contact | James Lee |
Correspondent | James Lee VORTRAN Medical Technology 1, Inc. 21 Goldenland Court #100 Sacramento, CA 95834 |
Product Code | BSK |
CFR Regulation Number | 868.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-22 |
Decision Date | 2018-05-25 |
Summary: | summary |