Labtron 202GY
Labtron 202GY is a Class II device made by GF Health Products, Inc., cleared under FDA 510(k) K092245 on 28 Oct 2009 and listed in FDA GUDID since 25 Aug 2020 (UDI-DI M368202GY1), active as of 8 Nov 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 | NumberM368202GY1 | Date25 Aug 2020 | StatusListed |
| United States | FDA 510(k) | NumberK092245 | Date28 Oct 2009 | StatusActive |
Official records
- FDA 510(k) database K092245
Across registries
- FDA 510(k) K092245 decided 28 Oct 2009 Active
- FDA GUDID UDI-DI M368202GY1 listed 25 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K092245
- Listed FDA GUDID M368202GY1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Labtron
- Generic name
- Aneroid manual sphygmomanometer
- Model / reference
- 202GY
- Primary DI / UDI-DI
- M368202GY1
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Aneroid manual sphygmomanometer
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- In Commercial Distribution
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