VC150 VITAL SIGNS MONITOR— 510(k) K133810
Substantially EquivalentInnokas Yhtyma
FDA 510(k) clearance K133810 for VC150 VITAL SIGNS MONITOR, Substantially Equivalent on 2014-10-30. Applicant: Innokas Yhtyma. Device class: 2.
Clearance details
- Applicant
- Innokas Yhtyma
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kempele, Oulu, FI
Recent devices under product code MWI
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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 →
Recalls naming K133810
K-number listed on FDA's recall record- Z-2604-2016 — CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
- Z-0264-2016 — CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
- Z-1022-2015 — VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133810.
Data sourced from openFDA. This site is unofficial and independent of the FDA.