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FDA 510(k)

TAP 3, TAP 1

K-Number: K160239 · 2016-08-10

ApplicantAirway Management, Inc.
Decision Date2016-08-10
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TAP 3, TAP 1 is the device name listed in this FDA 510(k) record. The listed applicant is Airway Management, Inc.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K160239. 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 TAP 3, TAP 1?

TAP 3, TAP 1 is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Airway Management, Inc.. The 510(k) number is K160239.

When did TAP 3, TAP 1 receive FDA 510(k) clearance?

TAP 3, TAP 1 received FDA 510(k) clearance on 2016-08-10, under 510(k) number K160239.

Who is the listed applicant for TAP 3, TAP 1?

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

What is the FDA product code for TAP 3, TAP 1?

The FDA product code for TAP 3, TAP 1 is PLC.

Other records listing Airway Management, Inc. as applicant

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.

K181482myTAP2

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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