Pen Panel Transmitter Box 21
by Neocoil, LLC
Pen Panel Transmitter Box 21 is a Class II device made by Neocoil, LLC, cleared under FDA 510(k) K133670 on 24 Jul 2014 and listed in FDA GUDID since 16 Mar 2017 (UDI-DI 00856181003213), 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 | Number00856181003213 | Date16 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133670 | Date24 Jul 2014 | StatusActive |
Official records
- AccessGUDID record 00856181003213
- FDA 510(k) database K133670
Across registries
- FDA 510(k) K133670 decided 24 Jul 2014 Active
- FDA GUDID UDI-DI 00856181003213 listed 16 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K133670
- Listed FDA GUDID 00856181003213
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pen Panel Transmitter Box
- Generic name
- Headphones
- Model / reference
- 21
- Primary DI / UDI-DI
- 00856181003213
- 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).
- ORTHO 8000 by Inner Vision Mri, Ltd.
- SIGNA 3.0T MAGNETIC RESONANCE SYSTEM by GE MEDICAL SYSTEMS, INC.
- BRIVO MR355, OPTIMA MR360 by GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- FLEXIBLE PHASED ARRAY SPINE COIL by Philips Medical Systems (Cleveland), Inc.
- HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST by Philips Medical Systems (Cleveland), Inc.
- CANVAS N-VAS-D 2.0 by Vassol, Inc.
- MAGNETIC RESONANCE DEVICE MRT 150A by Toshiba America Mri, Inc.
- Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 by Philips Medical Systems Nederland B.V.
- RTHawk, HeartVista Workstation with RTHawk by Heartvista, Inc.
- MRH-500 by Hitachi Medical Systems America, Inc.