ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)— 510(k) K173624
Substantially EquivalentOrigio A/S
FDA 510(k) clearance K173624 for ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311), Substantially Equivalent on 2018-03-02. Applicant: Origio A/S. Device class: 2.
Clearance details
- Applicant
- Origio A/S
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Måløv, DK
Recent devices under product code MQL
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