LogoFDA 510(k) Search
K Number
K954804
Device Name
LUNG DIFFUSION MIXTURES
Manufacturer
MITTLER SUPPLY, INC.
Date Cleared
1996-01-25

(98 days)

Product Code
BXK
Regulation Number
868.6400
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.6400 Calibration gas.

(a)
Identification. A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.