FDA 510(k)

TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050

K-Number: K051583 · 2005-11-04

Decision Date2005-11-04

Product CodeBZD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 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 2005-11-04 under 510(k) number K051583. 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 TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050?

TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 is a medical device that received FDA 510(k) clearance on 2005-11-04. The listed applicant is Tiara Medical Systems, Inc.. The 510(k) number is K051583.

When did TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 receive FDA 510(k) clearance?

TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 received FDA 510(k) clearance on 2005-11-04, under 510(k) number K051583.

Who is the listed applicant for TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050?

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 TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050?

The FDA product code for TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 is BZD.

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Other records listing Tiara Medical Systems, Inc. as applicant

K043382TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 K034053TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 K031935TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 K012207ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 K992192AIRPILOTMASK, MODEL TMS-900 K964092TMS COMFORT SERIES NASAL CPAP MASK

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Related Devices (Code: BZD)

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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.