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FDA 510(k)

MISTASSIST BREATHING EXERCISER

K-Number: K953055 · 1996-02-08

ApplicantThe Merlin Corp.
Decision Date1996-02-08
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MISTASSIST BREATHING EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is The Merlin Corp.. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K953055. 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 MISTASSIST BREATHING EXERCISER?

MISTASSIST BREATHING EXERCISER is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is The Merlin Corp.. The 510(k) number is K953055.

When did MISTASSIST BREATHING EXERCISER receive FDA 510(k) clearance?

MISTASSIST BREATHING EXERCISER received FDA 510(k) clearance on 1996-02-08, under 510(k) number K953055.

Who is the listed applicant for MISTASSIST BREATHING EXERCISER?

The FDA 510(k) record lists The Merlin Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISTASSIST BREATHING EXERCISER?

The FDA product code for MISTASSIST BREATHING EXERCISER 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 The Merlin Corp. 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.

K942789MISTASSIST

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

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

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