The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model 78353b.
Device ID | K842817 |
510k Number | K842817 |
Device Name: | MODEL 78353B |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | HEWLETT-PACKARD CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-18 |
Decision Date | 1985-06-06 |