The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for M1730b Tracemaster Ecg System, M1766b Local Edit Station, M1798b Remote Edit Station.
Device ID | K974420 |
510k Number | K974420 |
Device Name: | M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | HEWLETT-PACKARD CO. 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Steven A Clarke |
Correspondent | Steven A Clarke HEWLETT-PACKARD CO. 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-24 |
Decision Date | 1998-02-19 |
Summary: | summary |