510(k) K222101
- Device
- Prism
- Applicant
- Graymatters Health , Ltd.
- 510(k) number
- K222101
- Product code
- HCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-17
- Date received
- 2022-07-18
- Regulation
- 882.5050
- Classification name
- Device, Biofeedback
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Adar Shani
- Address
- 82 Ha’ Atzmaut St. Haifa IL
FDA Registration Numbers#
- 1223851
- 3039260720
- 1423537
- 3042226194
- 3006240003
- 1721293
- 3007075140
- 9680487
- 3015497638
- 3009351773
- 1531052
- 3012697062
- 3030198312
- 3009466220
- 3014209670
- 3016159413
- 3038620647
- 3018317166
- 3009862126
- 3007799236
- 3018783526
- 3006978331
- 8021957
- 3010361494
- 3012164803
- 3013413442
- 3016660162
- 3003755374
- 3017936974
- 3014128880
- 1921846
- 9616086
- 1528764
- 3005998761
- 3007502541
- 3009475597
- 1911273
- 3009118691
- 3006418479
- 3008414621
- 3038189172
- 3010872373
- 3029923663
- 3015526174
- 3006644670
- 3016566173
- 3006177498
- 3013401749
- 3013263129
- 3027475369
- 3023272766
- 3012316249
- 3004076349
- 1224842
- 3010887638
- 3005024415
- 3007712511
- 2084126
- 3017264244
- 3007608780
- 2518422
- 3015392301
- 1417592
- 3013517104
- 3011905669
- 3027256314
- 3005170249
- 3004642067
- 3011410128
- 1930027
- 3015489139
- 3007028037
- 3016735640
- 3000126629
- 3006789226
- 3004839404
- 3014937917
- 3019892999
- 3010078139
Source Documents#
Other 510(k) Records For Product Code HCC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233580 | A Breathing System (ABS) | Deepwell Dtx, Inc. | 2024-08-01 |
| K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018-08-23 |
| K163448 | GrindCare System | Sunstar Suisse S.A. | 2017-09-01 |
| K151050 | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | 2015-12-22 |
| K143507 | NFANT Feeding Solution | Nfant Labs, LLC | 2015-09-09 |
| K131586 | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | 2013-12-10 |
| K122879 | EEGER4 MODEL 4.3 | Eeg Software, LLC | 2013-02-06 |
| K111687 | EMG SYSTEM | Myotronics-Noromed, Inc. | 2011-09-29 |
| K092675 | GRINDCARE | Medotech A/S | 2010-03-03 |
| K073557 | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | 2008-02-28 |
| K071866 | NTRAINER SYSTEM | Kcbiomedix, Inc. | 2008-02-01 |
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | 2007-09-05 |
| K041244 | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | 2004-08-12 |
| K020399 | RESPERATE; MODEL RR-150 | Intercure , Ltd. | 2002-07-02 |
| K010388 | SONDREX P.A.L. SYSTEM | Ohmeda Medical | 2001-12-11 |