510(k) K221477
- Device
- AG100s
- Applicant
- Hospitech Respiration , Ltd.
- 510(k) number
- K221477
- Product code
- BSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-29
- Date received
- 2022-05-23
- Regulation
- 868.5750
- Classification name
- Cuff, Tracheal Tube, Inflatable
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yoel Bergman
- Address
- 15 Atir Yeda Kfar Saba IL 446312 446312
FDA Registration Numbers#
- 3029906224
- 3007014520
- 3042254935
- 2031966
- 2182318
- 3012072872
- 2518436
- 3007740622
- 3007048256
- 2022648
- 9616567
- 3014766741
- 3009959868
- 1221763
- 1056553
- 8010485
- 3007682555
- 3014254831
- 3011481350
- 3009050824
- 3016548968
- 3043543260
- 3010806663
- 3018226067
- 3004992992
- 8010939
- 3009307931
- 1417592
- 2951529
- 3003935342
- 3006024395
- 3006673317
- 1047843
- 3018094310
- 3009973505
- 3010326740
- 3005803389
- 3012307300
- 3011137372
- 3016438694
- 3007713076
- 3030412764
- 2936999
- 3004593495
- 1314417
- 3004365956
Source Documents#
Other 510(k) Records For Product Code BSK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243562 | CuffGuard | Idmed | 2025-08-12 |
| K242642 | CuffTrek | Shanghai Longmann Tech Co., Ltd. | 2025-03-07 |
| K220854 | TrachCuff Cuff Controller | Aw Technologies Aps | 2023-04-14 |
| K202874 | Puritan Bennett Cuff Pressure Manager | Covidien, LLC | 2021-01-09 |
| K192611 | Cuffix | Biovo Technologies , Ltd. | 2020-08-13 |
| K191858 | Pylant Monitor | Kal-Med, LLC | 2020-02-24 |
| K182548 | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | 2019-01-25 |
| K180991 | AG 100s | Hospitech Respiration , Ltd. | 2018-10-12 |
| K173914 | VORTRAN Cuff Inflator (VCI) | Vortran Medical Technology 1, Inc. | 2018-05-25 |
| K152778 | TRACOE Cuff Pressure Monitor | Tracoe Medical GmbH | 2016-12-21 |
| K152865 | TRACOE smart Cuff Manager | Tracoe Medical GmbH | 2016-09-27 |
| K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration , Ltd. | 2016-02-16 |
| K150893 | IntelliCuff | Hamilton Medical AG | 2016-01-29 |
| K142103 | CUFF PILOT, SURE SEAL | Teleflexmedical, Inc. | 2015-05-08 |
| K122721 | AG GUFFILL | Hospitech Respiration , Ltd. | 2013-05-03 |