The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model M1175a/m1176a With St Segment Monitoring.
Device ID | K900032 |
510k Number | K900032 |
Device Name: | MODEL M1175A/M1176A WITH ST SEGMENT MONITORING |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Contact | Nicholas Poly |
Correspondent | Nicholas Poly HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-02 |
Decision Date | 1990-04-10 |