EEG BIOFEEDBACK DEVICE
FDA 510(k) clearance K842022 · decided 1984-07-20
Clearance details
- K-number
- K842022
- Device name
- EEG BIOFEEDBACK DEVICE
- Applicant
- Electronics Research & Production
- Decision
- Substantially Equivalent
- Date received
- 1984-05-18
- Decision date
- 1984-07-20
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HCC
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Electronics Research & Production
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| A Breathing System (ABS) (K233580) | Deepwell Dtx, Inc. | 2024-08-01 |
| Prism (K222101) | Graymatters Health , Ltd. | 2023-03-17 |
| Freespira (K180173) | Palo Alto Health Sciences, Inc. | 2018-08-23 |
| GrindCare System (K163448) | Sunstar Suisse S.A. | 2017-09-01 |
| Pacifier Activated Lullaby (PAL®) (K151050) | Power Medical Devices, LLC | 2015-12-22 |
| NFANT Feeding Solution (K143507) | Nfant Labs, LLC | 2015-09-09 |
| CANARY BREATHING SYSTEM (K131586) | Palo Alto Health Sciences, Inc. | 2013-12-10 |
| EEGER4 MODEL 4.3 (K122879) | Eeg Software, LLC | 2013-02-06 |
| EMG SYSTEM (K111687) | Myotronics-Noromed, Inc. | 2011-09-29 |
| GRINDCARE (K092675) | Medotech A/S | 2010-03-03 |
| EEG NEUROAMP, MODEL CS10137 (K073557) | Corscience GmbH & Co. KG | 2008-02-28 |
| NTRAINER SYSTEM (K071866) | Kcbiomedix, Inc. | 2008-02-01 |
Recalls involving this device
No recalls on record reference this clearance.