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FDA 510(k)

MicrO2 OSA Device with Micro-Recorder

K-Number: K161624 · 2016-11-07

ApplicantMicrodental, Inc.
Decision Date2016-11-07
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MicrO2 OSA Device with Micro-Recorder is a medical device manufactured by Microdental, Inc.. It received FDA 510(k) clearance on 2016-11-07 under approval number K161624. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicrO2 OSA Device with Micro-Recorder?

MicrO2 OSA Device with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2016-11-07. It is manufactured by Microdental, Inc.. The 510(k) number is K161624.

When was MicrO2 OSA Device with Micro-Recorder approved by the FDA?

MicrO2 OSA Device with Micro-Recorder received FDA 510(k) clearance on 2016-11-07, under approval number K161624.

What company makes MicrO2 OSA Device with Micro-Recorder?

MicrO2 OSA Device with Micro-Recorder is manufactured by Microdental, Inc..

What is the FDA product code for MicrO2 OSA Device with Micro-Recorder?

The FDA product code for MicrO2 OSA Device with Micro-Recorder is PLC.

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Related Devices (Code: PLC)

K160239TAP 3, TAP 1Airway Management, Inc. K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep Technologies K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc. K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services K233497Rest Assure SystemSomnomed, Inc.

Official Source

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

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