The following data is part of a premarket notification filed by Obmedical Company with the FDA for Laborview Lv1000.
| Device ID | K142583 |
| 510k Number | K142583 |
| Device Name: | LaborView LV1000 |
| Classification | Uterine Electromyographic Monitor |
| Applicant | OBMedical Company 107 SW 140th Terrace, Suite 1 Newberry, FL 32669 |
| Contact | Suha Jhaveri |
| Correspondent | Paul Dryden PROMEDIC, INC. 107 SW 140TH TERRACE, SUITE 1 Newberry, FL 32669 |
| Product Code | OSP |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2015-01-16 |
| Summary: | summary |