The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Portable, Electrocardiograph (ecg) Monitor, Model Hcg-801.
| Device ID | K060766 |
| 510k Number | K060766 |
| Device Name: | PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 |
| Classification | Electrocardiograph |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Donna Djinovich |
| Correspondent | Silvia Ankova UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-22 |
| Decision Date | 2006-06-09 |
| Summary: | summary |