The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Cardio-3 Channel Electrocardiograph.
| Device ID | K850454 |
| 510k Number | K850454 |
| Device Name: | CARDIO-3 CHANNEL ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH JUNKERSSTRABE 9 POSTFACH 22 80 7910 Neu-ulm, Germany, DE |
| Contact | Detlef Gansera |
| Correspondent | Detlef Gansera ZIMMER ELEKTROMEDIZIN GMBH JUNKERSSTRABE 9 POSTFACH 22 80 7910 Neu-ulm, Germany, DE |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-06 |
| Decision Date | 1985-03-01 |