The following data is part of a premarket notification filed by Impedimed Limited with the FDA for Impedimed - Bis Extra Cellular Fluid Analysis.
| Device ID | K130338 |
| 510k Number | K130338 |
| Device Name: | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS |
| Classification | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Applicant | IMPEDIMED LIMITED 555 13TH STREET, NW Washington, DC 20004 |
| Contact | John J Smith, M.d., J.d. |
| Correspondent | John J Smith, M.d., J.d. IMPEDIMED LIMITED 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | OBH |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-11 |
| Decision Date | 2013-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B227252LDEXU4002 | K130338 | 000 |
| B277242LDEXU4002 | K130338 | 000 |
| B277222LDEXU4002 | K130338 | 000 |