The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Cardio 7.
| Device ID | K113306 |
| 510k Number | K113306 |
| Device Name: | CARDIO 7 |
| Classification | Electrocardiograph |
| Applicant | BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 Irvine, CA 92604 |
| Contact | Marc Goodman |
| Correspondent | Marc Goodman BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 Irvine, CA 92604 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-09 |
| Decision Date | 2012-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809276943559 | K113306 | 000 |