FDA UDI
In Commercial Distribution
🇺🇸 United States
neo
DI: B195LE800
·
Model: LE-800
·
eemagine Medical Imaging Solutions GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- neo
- Primary DI
- B195LE800
- Version / Model
- LE-800
- Company Name
- eemagine Medical Imaging Solutions GmbH
- Labeler DUNS
- 313152485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-26
- Public Version
- 2
- Public Version Date
- 2025-09-30
- Public Version Status
- Update
- Public Device Record Key
- 2a2377f1-74ab-470b-a6d5-4b36d34c93ca
Device Description
aEEG monitoring
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OMA | Amplitude-integrated electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38736 | Electroencephalographic monitoring system | An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B195LE800 | HIBCC |
Customer Contacts
- Phone
- +493029048404
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192889 | 000 |