LaborView™ LV1000 Wireless Electrode System
Uterine Electromyographic Monitor
OBMedical Company
The following data is part of a premarket notification filed by Obmedical Company with the FDA for Laborview™ Lv1000 Wireless Electrode System.
Pre-market Notification Details
| Device ID | K190798 |
| 510k Number | K190798 |
| Device Name: | LaborView™ LV1000 Wireless Electrode System |
| Classification | Uterine Electromyographic Monitor |
| Applicant | OBMedical Company 3630 SW 47th Ave, Suite 201 Gainesville, FL 32608 |
| Contact | Mark A. Samuels |
| Correspondent | Paul Dryden OBMedical Company 3630 SW 47th Ave, Suite 201 Gainesville, FL 32608 |
| Product Code | OSP |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-28 |
| Decision Date | 2020-09-18 |
Trademark Results [LaborView]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LABORVIEW 85738011 4660080 Live/Registered |
OBMedical Company 2012-09-25 |
 LABORVIEW 85321144 not registered Dead/Abandoned |
Labor Logix, INC., Orland Park, IL 2011-05-14 |
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