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K Number
K120145
Device Name
SIMPLE T NASAL MASK
Manufacturer
RESPIRONICS INC.
Date Cleared
2012-03-30

(72 days)

Product Code
BZD
Regulation Number
868.5905
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Simple T Nasal Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospitallinstitutional environment. The mask is to be used by patients greater than 66lbs/30kg.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Simple T Nasal Mask." It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter primarily:

  • Confirms that the FDA has reviewed the premarket notification (K120145) for the Simple T Nasal Mask.
  • States that the device is substantially equivalent to legally marketed predicate devices.
  • Outlines general regulatory requirements for marketing the device.
  • Provides contact information for further regulatory guidance.
  • Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information from this document.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).