Seaduc EMI700
Seaduc EMI700 is a Class I device made by Em Innovations Inc, cleared under FDA 510(k) K882017 on 14 Jul 1988 and listed in FDA GUDID since 21 Oct 2022 (UDI-DI 00860007555336), active as of 22 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 | Number00860007555336 | Date21 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK882017 | Date14 Jul 1988 | StatusActive |
Official records
- AccessGUDID record 00860007555336
- FDA 510(k) database K882017
Across registries
- FDA 510(k) K882017 decided 14 Jul 1988 Active
- FDA GUDID UDI-DI 00860007555336 listed 21 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K882017
- Listed FDA GUDID 00860007555336
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Seaduc
- Generic name
- Emergency airway clearance suction pump, manual
- Model / reference
- EMI700
- Primary DI / UDI-DI
- 00860007555336
- 510(k) Number
- FDA product code
- BSY
- GMDN term
- Emergency airway clearance suction pump, manual
- Device class
- Class I
- Regulation number
- 868.6810
- GUDID distribution status
- In Commercial Distribution
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