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FDA 510(k)

MIST-EASE NEBULIZER

K-Number: K844591 · 1984-12-13

ApplicantGeneral Physiotherapy, Inc.
Decision Date1984-12-13
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MIST-EASE NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is General Physiotherapy, Inc.. It received FDA 510(k) clearance on 1984-12-13 under 510(k) number K844591. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIST-EASE NEBULIZER?

MIST-EASE NEBULIZER is a medical device that received FDA 510(k) clearance on 1984-12-13. The listed applicant is General Physiotherapy, Inc.. The 510(k) number is K844591.

When did MIST-EASE NEBULIZER receive FDA 510(k) clearance?

MIST-EASE NEBULIZER received FDA 510(k) clearance on 1984-12-13, under 510(k) number K844591.

Who is the listed applicant for MIST-EASE NEBULIZER?

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

What is the FDA product code for MIST-EASE NEBULIZER?

The FDA product code for MIST-EASE NEBULIZER is CCQ.

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Other records listing General Physiotherapy, 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.

K870939VIBRACAREK863383FACIAL MASSAGER, BATTERY POWEREDK861834THERACUSHION MODEL 1000K855129NEOCUSSOR (MASSAGER, BATTERY) POWEREDK853710THERACUSHIONK852944FLEXIMATIC MASSAGER

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Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, Inc.

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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