Cleared Traditional

Safey Peak Flow Meter

K200832 · Safey Medical Devices Pvt, Ltd. · Anesthesiology

Jul 2020

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K200832 is an FDA 510(k) clearance for the Safey Peak Flow Meter, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Safey Medical Devices Pvt, Ltd. (Pune, IN). The FDA issued a Cleared decision on July 30, 2020, 122 days after receiving the submission on March 30, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number	K200832 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2020
Decision Date	July 30, 2020
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF