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FDA 510(k)

SPIRO-BALL

K-Number: K053149 · 2005-12-13

ApplicantLeventon, S.A.
Decision Date2005-12-13
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRO-BALL is the device name listed in this FDA 510(k) record. The listed applicant is Leventon, S.A.. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K053149. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRO-BALL?

SPIRO-BALL is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Leventon, S.A.. The 510(k) number is K053149.

When did SPIRO-BALL receive FDA 510(k) clearance?

SPIRO-BALL received FDA 510(k) clearance on 2005-12-13, under 510(k) number K053149.

Who is the listed applicant for SPIRO-BALL?

The FDA 510(k) record lists Leventon, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRO-BALL?

The FDA product code for SPIRO-BALL is BWF.

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.

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Other records listing Leventon, S.A. 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.

K040752DOSI-FUSERK994074TRI-BALLK952810DOSI-FLOW, MODELS 20 & 30K851058DOSI FLOW

Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, 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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