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 a medical device manufactured by Mark Abramson, D.D.S., Inc.. It received FDA 510(k) clearance on 2019-04-19 under approval 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. It is manufactured by Mark Abramson, D.D.S., Inc.. The 510(k) number is K181571.
When was OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor approved by the FDA?
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor received FDA 510(k) clearance on 2019-04-19, under approval number K181571.
What company makes 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 manufactured by Mark Abramson, D.D.S., Inc..
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.
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Official Source
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