HOME BLOOD PRESSURE KIT, ANEROID— 510(k) K884420
Substantially EquivalentYamasu Co. , Ltd.
FDA 510(k) clearance K884420 for HOME BLOOD PRESSURE KIT, ANEROID, Substantially Equivalent on 1989-08-25. Applicant: Yamasu Co. , Ltd.. Device class: 3.
Clearance details
- Applicant
- Yamasu Co. , Ltd.
- Product code
- Code DXY
- Device class
- Class 3
- Regulation
- 21 CFR 870.3610
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saitama Pref., JP
Recent devices under product code DXY
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- K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS
- K945627 — PIKOS LP 01, PIKOS LP E01
- K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
- K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
More clearances from Yamasu Co. , Ltd.
view allAdverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
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.