The following data is part of a premarket notification filed by Skanray Technologies Pvt Ltd. with the FDA for Star 90.
| Device ID | K150512 |
| 510k Number | K150512 |
| Device Name: | STAR 90 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SKANRAY TECHNOLOGIES PVT LTD. # 15-17 HEBBAL INDUSTRIAL AREA Mysore, IN 570016 |
| Contact | Hema ` Singh |
| Correspondent | Yolanda Smith Smith Assoicates 1468 Harwell Avenue 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 | 2015-02-27 |
| Decision Date | 2015-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18904269452046 | K150512 | 000 |
| 18904269452053 | K150512 | 000 |