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 |