Sentinel P1 Audio Interface Module 76
by Neocoil, LLC
Sentinel P1 Audio Interface Module 76 is a Class II device made by Neocoil, LLC, cleared under FDA 510(k) K173409 on 16 Feb 2018 and listed in FDA GUDID since 26 Apr 2018 (UDI-DI 00856181003763), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00856181003763 | Date26 Apr 2018 | StatusListed |
| United States | FDA 510(k) | NumberK173409 | Date16 Feb 2018 | StatusActive |
Official records
- AccessGUDID record 00856181003763
- FDA 510(k) database K173409
Across registries
- FDA 510(k) K173409 decided 16 Feb 2018 Active
- FDA GUDID UDI-DI 00856181003763 listed 26 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K173409
- Listed FDA GUDID 00856181003763
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sentinel P1 Audio Interface Module
- Generic name
- Headphones
- Model / reference
- 76
- Primary DI / UDI-DI
- 00856181003763
- 510(k) Number
- FDA product code
- LNH
- GMDN term
- Headphones
- Device class
- Class II
- Regulation number
- 892.1000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).
- MAGNETOM Sola; MAGNETOM Altea by SIEMENS MEDICAL SOLUTIONS USA, INC.
- MAGNETOM ESSENZA WITH SYNGO MR D14 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI by Instrumentarium Imaging, Inc.
- MAGNETOM by Siemens Corp.
- uMR570 by Shanghai United Imaging Healthcare Co., Ltd.
- E-SCAN by Biosound Esaote, Inc.
- MRT 50A CRANIO-CERVICAL COIL by Toshiba America Mri, Inc.
- INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM by Medical Numerics, Inc.
- BRIVO MR355, OPTIMA MR360 by GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- MRH-1500 by Hitachi Medical Systems America, Inc.