MINIVISOR— 510(k) K780035
Substantially EquivalentMetrix Teknika, Inc.
FDA 510(k) clearance K780035 for MINIVISOR, Substantially Equivalent on 1978-03-06. Applicant: Metrix Teknika, Inc.. Device class: 2.
Clearance details
- Applicant
- Metrix Teknika, Inc.
- Product code
- Code HEL
- Device class
- Class 2
- Regulation
- 21 CFR 884.2660
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code HEL
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