Pouch 001-400-0027
Pouch 001-400-0027 (704554) is a Class II device made by Global Instrumentation LLC, cleared under FDA 510(k) K051730 on 26 Sep 2005 and listed in FDA GUDID since 21 Oct 2016 (UDI-DI 90815187020320), 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 | Number90815187020320 | Date21 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051730 | Date26 Sep 2005 | StatusActive |
Official records
- AccessGUDID record 90815187020320
- FDA 510(k) database K051730
Across registries
- FDA 510(k) K051730 decided 26 Sep 2005 Active
- FDA GUDID UDI-DI 90815187020320 listed 21 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K051730
- Listed FDA GUDID 90815187020320
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pouch
- Generic name
- Electrocardiographic ambulatory recorder
- Model / Ref / Catalog
- 001-400-0027, 704554
- Primary DI / UDI-DI
- 90815187020320
- 510(k) Number
- FDA product code
- MLO
- GMDN term
- Electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
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