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FDA 510(k)

MONAGHAN AEROCHAMBER

K-Number: K822437 · 1982-11-03

ApplicantMonaghan Medical Corp.
Decision Date1982-11-03
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONAGHAN AEROCHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corp.. It received FDA 510(k) clearance on 1982-11-03 under 510(k) number K822437. The device is classified under product code BYP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONAGHAN AEROCHAMBER?

MONAGHAN AEROCHAMBER is a medical device that received FDA 510(k) clearance on 1982-11-03. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K822437.

When did MONAGHAN AEROCHAMBER receive FDA 510(k) clearance?

MONAGHAN AEROCHAMBER received FDA 510(k) clearance on 1982-11-03, under 510(k) number K822437.

Who is the listed applicant for MONAGHAN AEROCHAMBER?

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

What is the FDA product code for MONAGHAN AEROCHAMBER?

The FDA product code for MONAGHAN AEROCHAMBER is BYP.

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Other records listing Monaghan Medical 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.

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Related Devices (Code: BYP)

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.

K955657NORTH STATE PLASTICS RESPIRATORY MOUTHPIECENorth State Plastics, Inc.K944512TRUZONE PFM DISPOSABLE MOUTHPIECEMonaghan Medical Corp.K893791BREATHING MOUTHPIECEDiemolding Corp.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, 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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