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FDA 510(k)

HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER

K-Number: K870027 · 1987-03-16

ApplicantSalter Labs
Decision Date1987-03-16
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K870027. 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 HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER?

HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Salter Labs. The 510(k) number is K870027.

When did HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER receive FDA 510(k) clearance?

HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER received FDA 510(k) clearance on 1987-03-16, under 510(k) number K870027.

Who is the listed applicant for HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER?

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

What is the FDA product code for HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER?

The FDA product code for HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER is CCQ.

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Other records listing Salter Labs as applicant

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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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