DIGITAL SPHYGMOMANOMETER
FDA 510(k) clearance K871371 · decided 1987-06-12
Clearance details
- K-number
- K871371
- Device name
- DIGITAL SPHYGMOMANOMETER
- Applicant
- Omron Tateisi Electronics Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-07
- Decision date
- 1987-06-12
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tokyo, 105 Japan, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.