The following data is part of a premarket notification filed by Higi Sh Llc with the FDA for Higi Station.
| Device ID | K151127 |
| 510k Number | K151127 |
| Device Name: | Higi Station |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | higi SH LLC 717 S Myrtle Ave Suite A Monrovia, CA 91016 |
| Contact | Colin Hill |
| Correspondent | Colin Hill higi SH LLC 717 S Myrtle Ave Suite A Monrovia, CA 91016 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-28 |
| Decision Date | 2015-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B416KMY8202F0 | K151127 | 000 |