Cleared Traditional

Neteera 130H-Plus Vital Sign Monitoring Sensor

K231733 · Neteera Technologies , Ltd. · Cardiovascular

Feb 2024

Decision

241d

Days

Class 2

Risk

About This 510(k) Submission

K231733 is an FDA 510(k) clearance for the Neteera 130H-Plus Vital Sign Monitoring Sensor, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Neteera Technologies , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on February 9, 2024, 241 days after receiving the submission on June 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K231733 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2023
Decision Date	February 09, 2024
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF