The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Se-601 Series Electrocardiograph.
Device ID | K090367 |
510k Number | K090367 |
Device Name: | SE-601 SERIES ELECTROCARDIOGRAPH |
Classification | Electrocardiograph |
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 | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-13 |
Decision Date | 2009-06-03 |
Summary: | summary |