Identity
- Trade Name
- micromed FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) . The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals. FDA UDI
- Model / Reference
- BRAIN QUICK FDA UDI
- Description
- The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) . The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928120910 FDA UDI
- 510(k) Number
- K171384 FDA UDI
- FDA Product Code
- OLV FDA UDIGWQ FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electroencephalograph
micromed by Micromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micromed, Inc.
Sources (1)
- FDA UDI 4951d11a-59c4-42c0-9ae9-40a7cfcda391 34 fields · synced May 30, 2026