HOME BLOOD PRESSURE KIT, ANEROID
FDA 510(k) clearance K884420 · decided 1989-08-25
Clearance details
- K-number
- K884420
- Device name
- HOME BLOOD PRESSURE KIT, ANEROID
- Applicant
- Yamasu Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-20
- Decision date
- 1989-08-25
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- DXY
- Device class
- 3
- Regulation number
- 870.3610
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saitama Pref., JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.