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K Number
K030374
Device Name
SONIK LDI 20 AIR
Manufacturer
EVIT LABS, INC.
Date Cleared
2003-08-25

(202 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To be used to convert liquid medication into aerosol for inhalation by patient.

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The provided text is an FDA 510(k) clearance letter for the Sonik LDI 20 Air Nebulizer, confirming its substantial equivalence to a predicate device.

The letter discusses:

  • The device trade name and regulation number.
  • The FDA's determination of substantial equivalence.
  • Regulatory requirements and general controls for the device.
  • Contact information for further guidance.
  • An "Indications for Use" statement for the device.

It does not include:

  • A table of acceptance criteria and reported device performance.
  • Details of a study conducted to demonstrate performance against specific criteria.
  • Information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).