The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Surveyor Telemetry Central Station.
Device ID | K060135 |
510k Number | K060135 |
Device Name: | MORTARA SURVEYOR TELEMETRY CENTRAL STATION |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 -3431 |
Contact | Harlan L Van Matre |
Correspondent | Harlan L Van Matre MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 -3431 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-19 |
Decision Date | 2006-05-15 |
Summary: | summary |