The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Smart Ecg Series Electrocardiograph, Models Se-3, Se-300a And 300b, Se-6, Se-600, Se-12, Se-12 Express And Se-1200.
Device ID | K091513 |
510k Number | K091513 |
Device Name: | SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 |
Classification | Electrocardiograph |
Applicant | EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
Contact | William Stern |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-05-22 |
Decision Date | 2009-07-24 |
Summary: | summary |