ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002— 510(k) K051514
Substantially EquivalentHypoguard USA, Inc.
FDA 510(k) clearance K051514 for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002, Substantially Equivalent on 2005-10-04. Applicant: Hypoguard USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Hypoguard USA, Inc.
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
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More clearances from Hypoguard USA, Inc.
view all- K053079 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
- K041881 — ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
- K033851 — DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
- K031388 — MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
- K024347 — EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
Adverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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.