FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
K Number: K071075
·
Decision May 25, 2007
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
21
Review Days
39
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
- K Number
- K071075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Corp.
- Date Received
- April 16, 2007
- Decision Date
- May 25, 2007
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
Wrist Blood Pressure Monitor (XW-05)
FDA 510(k)
FDA Class 2
·Cardiovascular
VicorderCS (VCS-SYS-1100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
FDA 510(k)
FDA Class 2
·Cardiovascular
Upper arm electronic blood pressure monitor (XB-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
Blood Pressure Monitor (W06LT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Terumo Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K100282 | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER | Feb 26, 2010 | Substantially Equivalent |
| K092372 | HEARTRAIL III GUIDING CATHETER | Sep 11, 2009 | Substantially Equivalent |
| K091417 | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A | May 22, 2009 | Substantially Equivalent |
| K090973 | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) | May 1, 2009 | Substantially Equivalent |
| K073474 | CAPIOX CIRCUIT CONNECTORS | Mar 5, 2008 | Substantially Equivalent |
| K071572 | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER | Jul 23, 2007 | Substantially Equivalent |
| K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | Jul 16, 2007 | Substantially Equivalent |
| K040783 | FOUNDATION | Oct 13, 2004 | Substantially Equivalent |
| K040210 | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR | Mar 3, 2004 | Substantially Equivalent |
| K033681 | GLIDESHEATH | Dec 11, 2003 | Substantially Equivalent |