The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Pc Ecg, Model Se-1010.
| Device ID | K092010 |
| 510k Number | K092010 |
| Device Name: | PC ECG, MODEL SE-1010 |
| 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 | 2009-07-06 |
| Decision Date | 2009-10-22 |
| Summary: | summary |