Identity
- Trade Name
- SleepView FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Portable Sleep Monitor for Home Sleep Testing FDA UDI
- Model / Reference
- SleepView II FDA UDI
- Description
- Portable Sleep Monitor for Home Sleep Testing FDA UDI
Identifiers
- Catalog Number
- 502-0169-1 FDA UDI
- Primary DI / UDI-DI
- B143502016910 FDA UDI
- 510(k) Number
- K042039 FDA UDI
- FDA Product Code
- GWQ 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
SleepView by Cleveland Medical Devices Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042039 also covers:
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- ReadyRip Belt — Cleveland Medical Devices Inc.
- ReadyRip Belt — Cleveland Medical Devices Inc.
- ReadyRip Belt — Cleveland Medical Devices Inc.
- ReadyRip Belt — Cleveland Medical Devices Inc.
- ReadyRip Belt — Cleveland Medical Devices Inc.
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
- Cleveland Medical Devices Inc.
Sources (1)
- FDA UDI 38adfef6-ef5e-4695-93c0-dbfc6beec191 35 fields · synced Jun 8, 2026