The following data is part of a premarket notification filed by Skanray Technologies Private Limited with the FDA for Spot Skan.
| Device ID | K152831 |
| 510k Number | K152831 |
| Device Name: | Spot Skan |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18904269450318 | K152831 | 000 |
| 18904269450301 | K152831 | 000 |