The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Zb-821 Telemetry Transmitter.
| Device ID | K945578 |
| 510k Number | K945578 |
| Device Name: | NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Penni L Pannell |
| Correspondent | Penni L Pannell NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921106631 | K945578 | 000 |
| 04931921000694 | K945578 | 000 |
| 00841983103452 | K945578 | 000 |
| 00841983103445 | K945578 | 000 |