(187 days)
Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.
Neo Nest Infant Transport Mattress
This document is a 510(k) clearance letter from the FDA for a medical device called the "DeNovo Products Neo Nest Gel Infant Transport Mattress". It does not contain any information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter is a regulatory approval, not a scientific study report. It indicates that the device has been deemed "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market.
Therefore, I cannot provide the requested information based on the provided text.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.