The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for The Phillips, Model Mp20,mp30,mp40,mp50,mp60,mp70,mp80,and Mp90 Intellivue Patient Monitors.
Device ID | K060221 |
510k Number | K060221 |
Device Name: | THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Contact | Herbert Van Dyk |
Correspondent | Herbert Van Dyk PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-30 |
Decision Date | 2006-02-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838072190 | K060221 | 000 |
20884838072002 | K060221 | 000 |
20884838072019 | K060221 | 000 |
20884838072026 | K060221 | 000 |
20884838072033 | K060221 | 000 |
20884838072040 | K060221 | 000 |
20884838072057 | K060221 | 000 |
20884838072064 | K060221 | 000 |
20884838072071 | K060221 | 000 |
20884838072095 | K060221 | 000 |
20884838072101 | K060221 | 000 |
20884838072118 | K060221 | 000 |
20884838072125 | K060221 | 000 |
20884838072132 | K060221 | 000 |
20884838071999 | K060221 | 000 |