The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Fetal & Maternal Monitor, Model F6, F9.
Device ID | K082602 |
510k Number | K082602 |
Device Name: | FETAL & MATERNAL MONITOR, MODEL F6, F9 |
Classification | System, Monitoring, Perinatal |
Applicant | EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
Contact | William Stern |
Correspondent | William Stern EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
Product Code | HGM |
CFR Regulation Number | 884.2740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-08 |
Decision Date | 2008-11-26 |
Summary: | summary |