Innokas Medical Oy
KEMPELE Pohjois-Pohjanmaa, FI
INNOKAS MEDICAL OY appears in FDA device records in KEMPELE Pohjois-Pohjanmaa, FI. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007615597 | 3007615597 | INNOKAS MEDICAL OY | Vihikari 10, KEMPELE Pohjois-Pohjanmaa 90440 FI | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2604-2016 | CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care. | A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. | Class II | Terminated | |
| Z-0264-2016 | CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans | Monitor may shut down unintentionally without restarting. | Class II | Terminated | |
| 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. | If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain