The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Cathstation - Model M1264b.
| Device ID | K961401 |
| 510k Number | K961401 |
| Device Name: | HP CATHSTATION - MODEL M1264B |
| Classification | Electrocardiograph |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Rob Butler |
| Correspondent | Rob Butler HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-11 |
| Decision Date | 1996-10-08 |
| Summary: | summary |