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 |