The following data is part of a premarket notification filed by Noninvasive Medical Technologies, Llc. with the FDA for Zoe Fluid Status Monitor.
| Device ID | K042113 |
| 510k Number | K042113 |
| Device Name: | ZOE FLUID STATUS MONITOR |
| Classification | Plethysmograph, Impedance |
| Applicant | NONINVASIVE MEDICAL TECHNOLOGIES, LLC. 4367 TUOLUMNE PLACE Carlsbad, CA 92008 |
| Contact | Alden Kay |
| Correspondent | Alden Kay NONINVASIVE MEDICAL TECHNOLOGIES, LLC. 4367 TUOLUMNE PLACE Carlsbad, CA 92008 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-05 |
| Decision Date | 2004-09-14 |
| Summary: | summary |