ULTRAMAX/MODEL NUMBER A1— 510(k) K960044
Substantially EquivalentEntlab OY
FDA 510(k) clearance K960044 for ULTRAMAX/MODEL NUMBER A1, Substantially Equivalent on 1996-08-02. Applicant: Entlab OY. Device class: 2.
Clearance details
- Applicant
- Entlab OY
- Product code
- Code LWI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, CA
Recent devices under product code LWI
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