Cleared Traditional

K213515 - WesperO2 (FDA 510(k) Clearance)

K213515 · Wesper, Inc. · Anesthesiology device

Jun 2022

Decision

220d

Days

Class 2

Risk

K213515 is an FDA 510(k) clearance for the WesperO2. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Wesper, Inc. (New York, US). The FDA issued a Cleared decision on June 10, 2022, 220 days after receiving the submission on November 2, 2021.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K213515 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 02, 2021
Decision Date	June 10, 2022
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF