DIGITAL SPHYGMOMANOMETER— 510(k) K871371
Substantially EquivalentOmron Tateisi Electronics Co.
FDA 510(k) clearance K871371 for DIGITAL SPHYGMOMANOMETER, Substantially Equivalent on 1987-06-12. Applicant: Omron Tateisi Electronics Co.. Device class: 2.
Clearance details
- Applicant
- Omron Tateisi Electronics Co.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, 105 Japan, JP
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- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Omron Tateisi Electronics Co.
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.