The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Arrhythmia Central Occ-7101.
| Device ID | K843287 |
| 510k Number | K843287 |
| Device Name: | ARRHYTHMIA CENTRAL OCC-7101 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | NIHON KOHDEN AMERICA, INC. 1652 DEERE AVENUE Irvine , CA 92714 - |
| Contact | Paul M Parashak |
| Correspondent | Paul M Parashak NIHON KOHDEN AMERICA, INC. 1652 DEERE AVENUE Irvine , CA 92714 - |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-21 |
| Decision Date | 1984-10-18 |