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FDA 510(k)

PULMO-AIDE MODEL 5610D

K-Number: K854520 · 1985-12-09

ApplicantThe Devilbiss Co.
Decision Date1985-12-09
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMO-AIDE MODEL 5610D is the device name listed in this FDA 510(k) record. The listed applicant is The Devilbiss Co.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K854520. 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 PULMO-AIDE MODEL 5610D?

PULMO-AIDE MODEL 5610D is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is The Devilbiss Co.. The 510(k) number is K854520.

When did PULMO-AIDE MODEL 5610D receive FDA 510(k) clearance?

PULMO-AIDE MODEL 5610D received FDA 510(k) clearance on 1985-12-09, under 510(k) number K854520.

Who is the listed applicant for PULMO-AIDE MODEL 5610D?

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

What is the FDA product code for PULMO-AIDE MODEL 5610D?

The FDA product code for PULMO-AIDE MODEL 5610D is CCQ.

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Other records listing The Devilbiss Co. 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.

K874041DEVILBISS MODEL 8500DK872094VACU-AIDEK872826ULTRA-NEB 99 ULTRASONIC NEBULIZERK872470DEVO/MC44 OXYGEN CONCENTRATORK852209DEVO/MC29 OXYGEN CONCENTRATOR MC29DK851695ULTRA-NEB 100 ULTRASONIC NEBULIZER

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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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