Premium Study Kit Extra Extra Large - Single
by Cleveland Medical Devices Inc.
Premium Study Kit Extra Extra Large - Single (602-0114) is a Class II device made by Cleveland Medical Devices Inc., cleared under FDA 510(k) K042039 on 17 Nov 2004 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI B14360201141), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB14360201141 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042039 | Date17 Nov 2004 | StatusActive |
Official records
- FDA 510(k) database K042039
Across registries
- FDA 510(k) K042039 decided 17 Nov 2004 Active
- FDA GUDID UDI-DI B14360201141 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K042039
- Listed FDA GUDID B14360201141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Premium Study Kit
- Generic name
- Electroencephalograph
- Model / Ref / Catalog
- Extra Extra Large - Single, 602-0114
- Primary DI / UDI-DI
- B14360201141
- 510(k) Number
- FDA product code
- GWQ
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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