The following data is part of a premarket notification filed by Zywie, Inc. with the FDA for Zywieai Software Library.
| Device ID | K142693 |
| 510k Number | K142693 |
| Device Name: | ZywieAI Software Library |
| Classification | Electrocardiograph |
| Applicant | Zywie, Inc. 12000 Findley Road, Suite 360 Johns Creek, GA 30097 |
| Contact | Latha Ganeshan |
| Correspondent | Jon Ward AJW TECHNOLOGY CONSULTANTS, INC. 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-02-20 |
| Summary: | summary |