OASIS— 510(k) K984218
Substantially EquivalentGlimex Corp.
FDA 510(k) clearance K984218 for OASIS, Substantially Equivalent on 1998-12-17. Applicant: Glimex Corp.. Device class: 2.
Clearance details
- Applicant
- Glimex Corp.
- Product code
- Code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Folsom, CA, US
Recent devices under product code HIS
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