The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Fetasonde Labor Status Display.
Device ID | K791037 |
510k Number | K791037 |
Device Name: | FETASONDE LABOR STATUS DISPLAY |
Classification | System, Monitoring, Perinatal |
Applicant | ROCHE MEDICAL ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HGM |
CFR Regulation Number | 884.2740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-05 |
Decision Date | 1979-09-04 |