The following data is part of a premarket notification filed by Noninvasive Medical Technologies, Inc. with the FDA for Zoefluid Status Monitor (model Zoe 2b).
| Device ID | K112830 |
| 510k Number | K112830 |
| Device Name: | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) |
| Classification | Plethysmograph, Impedance |
| Applicant | NONINVASIVE MEDICAL TECHNOLOGIES, INC. 6412 S. ARVILLE STREET Las Vegas, NV 89118 |
| Contact | Marc O'griofa |
| Correspondent | Marc O'griofa NONINVASIVE MEDICAL TECHNOLOGIES, INC. 6412 S. ARVILLE STREET Las Vegas, NV 89118 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2012-11-13 |
| Summary: | summary |