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FDA 510(k)

MEDSHIELD/AEROCHAMBER

K-Number: K961455 · 1996-07-25

ApplicantDiemolding Corp.
Decision Date1996-07-25
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDSHIELD/AEROCHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Diemolding Corp.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K961455. 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 MEDSHIELD/AEROCHAMBER?

MEDSHIELD/AEROCHAMBER is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Diemolding Corp.. The 510(k) number is K961455.

When did MEDSHIELD/AEROCHAMBER receive FDA 510(k) clearance?

MEDSHIELD/AEROCHAMBER received FDA 510(k) clearance on 1996-07-25, under 510(k) number K961455.

Who is the listed applicant for MEDSHIELD/AEROCHAMBER?

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

What is the FDA product code for MEDSHIELD/AEROCHAMBER?

The FDA product code for MEDSHIELD/AEROCHAMBER is CCQ.

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Other records listing Diemolding 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.

K962749THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORTK902713ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANSK902114CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITORK900754RESPIREX 2K893791BREATHING MOUTHPIECEK781759RESCAL

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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.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, Inc.K900576MODIFIED AEROCHAMBER WITH MASKMonaghan Medical Corp.

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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