The following data is part of a premarket notification filed by Skanray Technologies Pvt Ltd with the FDA for Star 65.
| Device ID | K172147 |
| 510k Number | K172147 |
| Device Name: | STAR 65 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Skanray Technologies Pvt Ltd #360, KIADB Industrial Area, Hebbal, Mysore, IN 570018 |
| Contact | Mahadevan J |
| Correspondent | Parul Chansoria Elexes 6494 Tralee Village Dr Dublin, CA 94568 |
| Product Code | MWI |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRS |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSF |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | KRB |
| Subsequent Product Code | MNR |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-17 |
| Decision Date | 2018-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18904269452886 | K172147 | 000 |