LIFEGUARD— 510(k) K022755
Substantially EquivalentMedtek, LLC
FDA 510(k) clearance K022755 for LIFEGUARD, Substantially Equivalent on 2002-09-24. Applicant: Medtek, LLC. Device class: 2.
Clearance details
- Applicant
- Medtek, LLC
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Recent devices under product code KHE
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