2GB SD Memory Card Model 1303
2GB SD Memory Card Model 1303 (A10-0011) is an electrocardiographic lead set (FDA Class II; FDA product code DSH, Recorder, Magnetic Tape, Medical) made by Vasomedical, Inc., cleared under FDA 510(k) K111180 on 28 Jun 2011 and listed in FDA GUDID since 29 Nov 2016 (UDI-DI 00817980020559), 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 | Number00817980020559 | Date29 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111180 | Date28 Jun 2011 | StatusActive |
Official records
- AccessGUDID record 00817980020559
- FDA 510(k) database K111180
Across registries
- FDA 510(k) K111180 decided 28 Jun 2011 Active
- FDA GUDID UDI-DI 00817980020559 listed 29 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K111180
- Listed FDA GUDID 00817980020559
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 2GB SD Memory Card
- Generic name
- Electrocardiographic lead set, reusable
- Model / Ref / Catalog
- Model 1303, A10-0011
- Primary DI / UDI-DI
- 00817980020559
- 510(k) Number
- FDA product code
- DSH
- GMDN term
- Electrocardiographic lead set, reusable
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
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