The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Se-601 Series Electrocardiograph.
| Device ID | K093869 |
| 510k Number | K093869 |
| 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 | 2009-12-17 |
| Decision Date | 2010-04-01 |
| Summary: | summary |