The following data is part of a premarket notification filed by Higi Sh Llc with the FDA for Higi Station (with Body Composition And Pan And Tilt Cuff Housing), Higi Station ( With Body Composition And Fixed Cuff Housing).
| Device ID | K172739 |
| 510k Number | K172739 |
| Device Name: | Higi Station (with Body Composition And Pan And Tilt Cuff Housing), Higi Station ( With Body Composition And Fixed Cuff Housing) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | higi SH LLC 800 Royal Oaks Dr. Suite 102 And 106 Monrovia, CA 91016 |
| Contact | Colin Hill |
| Correspondent | Colin Hill higi SH LLC 800 Royal Oaks Dr. Suite 102 And 106 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 | 2017-09-12 |
| Decision Date | 2017-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146ZT2776A00210 | K172739 | 000 |