The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Transmitter, Zs-940pa Series.
| Device ID | K043517 |
| 510k Number | K043517 |
| Device Name: | TRANSMITTER, ZS-940PA SERIES |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Serrah Namini |
| Correspondent | Serrah Namini NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841983103909 | K043517 | 000 |
| 00841983103483 | K043517 | 000 |
| 00841983102974 | K043517 | 000 |
| 00841983102950 | K043517 | 000 |
| 00841983102943 | K043517 | 000 |
| 00841983102936 | K043517 | 000 |
| 00841983102929 | K043517 | 000 |
| 00841983102912 | K043517 | 000 |
| 00841983102905 | K043517 | 000 |
| 00841983101861 | K043517 | 000 |
| 00841983101854 | K043517 | 000 |
| 00841983101786 | K043517 | 000 |
| 00841983103490 | K043517 | 000 |
| 00841983103902 | K043517 | 000 |
| 04931921888667 | K043517 | 000 |
| 04931921888650 | K043517 | 000 |
| 04931921872246 | K043517 | 000 |
| 04931921872239 | K043517 | 000 |
| 04931921115213 | K043517 | 000 |
| 04931921115107 | K043517 | 000 |
| 04931921115091 | K043517 | 000 |
| 04931921115084 | K043517 | 000 |
| 04931921115077 | K043517 | 000 |
| 04931921106617 | K043517 | 000 |
| 04931921106600 | K043517 | 000 |
| 00841983101779 | K043517 | 000 |