Star 60
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
SKANRAY TECHNOLOGIES PRIVATE LIMITED
The following data is part of a premarket notification filed by Skanray Technologies Private Limited with the FDA for Star 60.
Pre-market Notification Details
| Device ID | K151512 |
| 510k Number | K151512 |
| Device Name: | Star 60 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SKANRAY TECHNOLOGIES PRIVATE LIMITED PLOT #360, KIADB INDUSTRIAL AREA, HEBBAL Mysore, IN 570018 |
| Contact | Mahadevan J |
| Correspondent | Yolanda Smith SMITH ASSOCIATES 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2016-02-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18904269450769 | K151512 | 000 |
| 01890426945073 | K151512 | 000 |
| 18904269450783 | K151512 | 000 |
Trademark Results [Star 60]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAR 60 88882361 not registered Live/Pending |
Studio 180 Design, Ltd. 2020-04-22 |
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