The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Model M1264b Cathstation.
Device ID | K952173 |
510k Number | K952173 |
Device Name: | HEWLETT-PACKARD MODEL M1264B CATHSTATION |
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 | 1995-05-08 |
Decision Date | 1995-08-11 |