FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

Device Name

Manufacturer

HEMO SAPIENS, INC.

Date Cleared

1997-06-10

(764 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Not Found.

Device Description

HOTMAN (Hemodynamic and Oxygen Transport Monitoring and Manaqing System)

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "HOTMAN (Hemodynamic and Oxygen Transport Monitoring and Managing System)". This document does not contain any information about the acceptance criteria or a study proving the device meets those criteria. It is purely a regulatory approval letter.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the input provided.

Summary

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.