The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model 43420b Newwave Holter System/modification.
| Device ID | K910291 |
| 510k Number | K910291 |
| Device Name: | MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-04-22 |