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FDA 510(k)

TMS COMFORT SERIES NASAL CPAP MASK

K-Number: K964092 · 1997-07-31

ApplicantTiara Medical Systems, Inc.
Decision Date1997-07-31
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TMS COMFORT SERIES NASAL CPAP MASK is the device name listed in this FDA 510(k) record. The listed applicant is Tiara Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K964092. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMS COMFORT SERIES NASAL CPAP MASK?

TMS COMFORT SERIES NASAL CPAP MASK is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Tiara Medical Systems, Inc.. The 510(k) number is K964092.

When did TMS COMFORT SERIES NASAL CPAP MASK receive FDA 510(k) clearance?

TMS COMFORT SERIES NASAL CPAP MASK received FDA 510(k) clearance on 1997-07-31, under 510(k) number K964092.

Who is the listed applicant for TMS COMFORT SERIES NASAL CPAP MASK?

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

What is the FDA product code for TMS COMFORT SERIES NASAL CPAP MASK?

The FDA product code for TMS COMFORT SERIES NASAL CPAP MASK is BZD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tiara Medical Systems, 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.

K051583TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050K043382TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840K034053TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040K031935TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530K012207ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530K992192AIRPILOTMASK, MODEL TMS-900

View all 7 devices →

Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

Official Source

View on FDA Database →

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

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