The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Minimon 7134b Patient Monitor.
| Device ID | K883069 |
| 510k Number | K883069 |
| Device Name: | MINIMON 7134B PATIENT MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | David Cromwick |
| Correspondent | David Cromwick KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-20 |
| Decision Date | 1989-01-17 |