The following data is part of a premarket notification filed by Ostar Meditech Corp. with the FDA for Ostar Usb Blood Pressure Monitor With Spectrum / P200 For Upper Arm, And M100 For Wrist Type.
| Device ID | K112269 |
| 510k Number | K112269 |
| Device Name: | OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OSTAR MEDITECH CORP. 5F, NO. 46-4, MIN-CHIUAN RD. SHING-TIEN DIST. New Taipei City, TW 231 |
| Contact | Steven Chang |
| Correspondent | Steven Chang OSTAR MEDITECH CORP. 5F, NO. 46-4, MIN-CHIUAN RD. SHING-TIEN DIST. New Taipei City, TW 231 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2011-10-20 |
| Summary: | summary |