PHEM-ALERT— 510(k) K032161
Substantially EquivalentFemtek,Llc.
FDA 510(k) clearance K032161 for PHEM-ALERT, Substantially Equivalent on 2003-09-30. Applicant: Femtek,Llc.. Device class: 1.
Clearance details
- Applicant
- Femtek,Llc.
- Product code
- Code LNW
- Device class
- Class 1
- Regulation
- 21 CFR 862.1550
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code LNW
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