ACCESSORY TO ECG ANALYSIS SYS.
FDA 510(k) clearance K781130 · decided 1978-08-23
Clearance details
- K-number
- K781130
- Device name
- ACCESSORY TO ECG ANALYSIS SYS.
- Applicant
- Oxford Medilog, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-05
- Decision date
- 1978-08-23
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- OMC
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Oxford Medilog
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 |
|---|---|---|
| Ceribell Monitor (K261101) | Ceribell, Inc. | 2026-06-30 |
| NX01 (NX01) (K251550) | Naox Technologies Sas | 2025-11-25 |
| SignalNED System (Model RE) (K251726) | Forest Devices, Inc. | 2025-09-03 |
| REMI Remote EEG Monitoring System (K243185) | Epitel | 2025-03-21 |
| Natus BrainWatch System (K242930) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 |
| QUEX ED; QUEX S (K232779) | Qx World, Ltd. | 2024-10-11 |
| SignalNED System (Model RE) (K242306) | Forest Devices, Inc. | 2024-09-04 |
| REMI Remote EEG Monitoring System (K230933) | Epitel, Inc. | 2023-06-30 |
| NEBA® Compact EEG2R Mobile Headset (K223628) | Neba Health, LLC | 2023-03-02 |
| Neurosteer EEG Recorder (K221563) | Neurosteer, Inc. | 2022-10-24 |
| REMI (K203827) | Epitel, Inc. | 2021-03-29 |
| Byteflies Kit (K192549) | Byteflies NV | 2020-06-22 |
Recalls involving this device
No recalls on record reference this clearance.