The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for M1765a Ecg Manager.
| Device ID | K974746 |
| 510k Number | K974746 |
| Device Name: | M1765A ECG MANAGER |
| Classification | Electrocardiograph |
| Applicant | HEWLETT-PACKARD CO. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | James R Veale |
| Correspondent | James R Veale HEWLETT-PACKARD CO. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-03-18 |
| Summary: | summary |