HEART SYNC
Automated External Defibrillators (non-wearable)
HEART SYNC INC.
The following data is part of a premarket notification filed by Heart Sync Inc. with the FDA for Heart Sync.
Pre-market Notification Details
| Device ID | K131494 |
| 510k Number | K131494 |
| Device Name: | HEART SYNC |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEART SYNC INC. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm HEART SYNC INC. 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-23 |
| Decision Date | 2013-09-16 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040016890 | K131494 | 000 |
| 00081350020008 | K131494 | 000 |
| 00863095000108 | K131494 | 000 |
| 90865292000106 | K131494 | 000 |
Trademark Results [HEART SYNC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEART SYNC 85170312 3989284 Live/Registered |
GRAPHIC CONTROLS ACQUISITION CORP. (MICHIGAN) 2010-11-05 |
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