The following data is part of a premarket notification filed by Tianjin Medis Medical Device Co., Ltd. with the FDA for Accucuff Cuff Pressure Indicator.
Device ID | K182548 |
510k Number | K182548 |
Device Name: | Accucuff Cuff Pressure Indicator |
Classification | Cuff, Tracheal Tube, Inflatable |
Applicant | Tianjin Medis Medical Device Co., Ltd. No. 15-A, Saida One Avenue, Xiqing Economic Development Area Tainjin, CN 300385 |
Contact | Yongzhi Wu |
Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
Product Code | BSK |
CFR Regulation Number | 868.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-17 |
Decision Date | 2019-01-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
16920687303601 | K182548 | 000 |
16920687300884 | K182548 | 000 |
16920687300877 | K182548 | 000 |