Healthstats International Pte. , Ltd.
Healthstats International Pte. , Ltd. has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- May 19, 2016 · VAI
- Latest 510(k)
- Jun 21, 2018
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 7 | Oct 4, 2026 | Not stated | Current |
| Inspections | 1 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 19, 2016 | Singapore, Singapore | Devices | Voluntary Action Indicated (VAI) | 3006551178 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Jun 21, 2018 |
| K131916 | BPROSOFT CASP PC SOFTWARE | Mar 11, 2014 |
| K131788 | HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE | Mar 4, 2014 |
| K101002 | A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 | Jun 8, 2010 |
| K072593 | A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE | Nov 15, 2007 |
| K060315 | HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Apr 7, 2006 |
| K051546 | BPCALIBRATOR MC3000/MC3100 | Jun 24, 2005 |