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FDA 510(k)

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor

K-Number: K181571 · 2019-04-19

ApplicantMark Abramson, D.D.S., Inc.
Decision Date2019-04-19
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Mark Abramson, D.D.S., Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K181571. 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 OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is Mark Abramson, D.D.S., Inc.. The 510(k) number is K181571.

When did OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor receive FDA 510(k) clearance?

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor received FDA 510(k) clearance on 2019-04-19, under 510(k) number K181571.

Who is the listed applicant for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

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

What is the FDA product code for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

The FDA product code for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor is PLC.

Related Clinical Trials

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.

NCT07353255Fibrescope vs Videolaryngoscope for Nasotracheal IntubationRECRUITINGNCT02962557Detecting Post-surgical Respiratory Compromise and Prompting Patients to Self-rescue: An Early Feasibility StudyACTIVE_NOT_RECRUITING

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 ServicesK172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep TechnologiesK170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic LabK161624MicrO2 OSA Device with Micro-RecorderMicrodental, 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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