The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Patient Monitor 78354a.
Device ID | K842236 |
510k Number | K842236 |
Device Name: | PATIENT MONITOR 78354A |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | HEWLETT-PACKARD CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Lenke |
Correspondent | Lenke HEWLETT-PACKARD CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-05 |
Decision Date | 1985-01-18 |