Hypocore
System, Hypothermia, Intravenous, Cooling
NOVOCOR MEDICAL SYSTEMS, INC
The following data is part of a premarket notification filed by Novocor Medical Systems, Inc with the FDA for Hypocore.
Pre-market Notification Details
| Device ID | K153162 |
| 510k Number | K153162 |
| Device Name: | Hypocore |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | NOVOCOR MEDICAL SYSTEMS, INC 2 DAVIS DRIVE Durham, NC 27709 |
| Contact | Tammy Carrea |
| Correspondent | Tammy Carrea NOVOCOR MEDICAL SYSTEMS, INC 2 DAVIS DRIVE Durham, NC 27709 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-05-24 |
| Summary: | summary |
Trademark Results [Hypocore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYPOCORE 87173998 5402631 Live/Registered |
CRS HOLDINGS INC. 2016-09-16 |
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