The following data is part of a premarket notification filed by Biogenix, Inc. with the FDA for Cardiorhythm 2000.
| Device ID | K841472 |
| 510k Number | K841472 |
| Device Name: | CARDIORHYTHM 2000 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | BIOGENIX, INC. 1225 BROKEN SOUND PKWY., N.W. Boca Raton, FL 33431 |
| Contact | James A Graham |
| Correspondent | James A Graham BIOGENIX, INC. 1225 BROKEN SOUND PKWY., N.W. Boca Raton, FL 33431 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-09 |
| Decision Date | 1984-10-29 |