The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Terumo Digital Blood Pressure Monitor Es-h55a.
| Device ID | K071075 |
| 510k Number | K071075 |
| Device Name: | TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TERUMO CORP. 44-1, 2-CHOME, HATAGAYA Shibuya-ku, Tokyo, JP 151-0072 |
| Contact | Yoshiaki Nagura |
| Correspondent | J A Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-05-25 |
| Summary: | summary |