The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Multi-parameter Module (m3000a)/display Unit (m3046a).
| Device ID | K971910 |
| 510k Number | K971910 |
| Device Name: | MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Contact | Egon Pfeil |
| Correspondent | Egon Pfeil HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1998-03-23 |