SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)

• K Number: K955482
• Device Name: SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
• Manufacturer: ADVANTAGE MEDICAL SERVICES, INC.
• Date Cleared: 1996-01-30 ( 90 days)
• Product Code: FOG
• Regulation Number: 868.5700
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 868.5700 Nonpowered oxygen tent.

(a)
Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.(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 § 868.9.