Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Wesper Lab

K-Number: K203343 · 2021-12-21

ApplicantWesper, Inc.
Decision Date2021-12-21
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Wesper Lab is a medical device manufactured by Wesper, Inc.. It received FDA 510(k) clearance on 2021-12-21 under approval number K203343. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wesper Lab?

Wesper Lab is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Wesper, Inc.. The 510(k) number is K203343.

When was Wesper Lab approved by the FDA?

Wesper Lab received FDA 510(k) clearance on 2021-12-21, under approval number K203343.

What company makes Wesper Lab?

Wesper Lab is manufactured by Wesper, Inc..

What is the FDA product code for Wesper Lab?

The FDA product code for Wesper Lab is MNR.

Other Devices by Wesper, Inc.

K213515WesperO2 K221816Wesper Lab K252628CASSIE

Related Devices (Code: MNR)

K153070Watch-PAT200UItamar Medical , Ltd. K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalSalter Labs K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. K163696SleepImage SystemMycardio, LLC Dba Sleepimage. K163665MATRx plusZephyr Sleep Technologies K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑