The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Surveyor Patient Monitor.
Device ID | K123556 |
510k Number | K123556 |
Device Name: | MORTARA SURVEYOR PATIENT MONITOR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
Contact | Amy Yang |
Correspondent | Amy Yang MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-19 |
Decision Date | 2013-03-22 |
Summary: | summary |