IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
FDA 510(k) clearance K080825 · decided 2008-10-03
Clearance details
- K-number
- K080825
- Device name
- IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
- Applicant
- Impedimed Pty , Ltd.
- Decision
- Unknown
- Date received
- 2008-03-24
- Decision date
- 2008-10-03
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- OBH
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pinkenba, Qld, AU
- Third-party review
- No
- Expedited review
- No
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| MoisturemeterD (K143310) | Delfin Technologies, Ltd. | 2015-11-19 |
| IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (K130338) | ImpediMed Limited | 2013-05-31 |
| IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (K100811) | ImpediMed Limited | 2011-11-04 |
| IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (K050415) | Impedimed Pty , Ltd. | 2007-03-30 |
Recalls involving this device
No recalls on record reference this clearance.