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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 the device name listed in this FDA 510(k) record. The listed applicant is Microdental, Inc.. It received FDA 510(k) clearance on 2016-11-07 under 510(k) 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. The listed applicant is Microdental, Inc.. The 510(k) number is K161624.

When did MicrO2 OSA Device with Micro-Recorder receive FDA 510(k) clearance?

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

Who is the listed applicant for MicrO2 OSA Device with Micro-Recorder?

The FDA 510(k) record lists Microdental, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: PLC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep TechnologiesK233497Rest Assure SystemSomnomed, Inc.K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep ServicesK181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc.K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep TechnologiesK170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab

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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