Cleared Traditional

Respiree Cardio-Respiratory Monitor

K223681 · Respiree Pte, Ltd. · Anesthesiology

Mar 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K223681 is an FDA 510(k) clearance for the Respiree Cardio-Respiratory Monitor, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Respiree Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on March 8, 2023, 90 days after receiving the submission on December 8, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K223681 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2022
Decision Date	March 08, 2023
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF