The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Multi-parameter Module, Model M3000a & Display Unit, Model M3046a.
| Device ID | K981576 |
| 510k Number | K981576 |
| Device Name: | MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | HEWLETT-PACKARD GMBH SCHICKARDSTRABE 4 Boeblingen, Baden-wttbg, DE D-71034 |
| Contact | Egon Pfeil |
| Correspondent | Egon Pfeil HEWLETT-PACKARD GMBH SCHICKARDSTRABE 4 Boeblingen, Baden-wttbg, DE D-71034 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-04 |
| Decision Date | 1998-07-17 |
| Summary: | summary |