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FDA 510(k)

TRUZONE PFM DISPOSABLE MOUTHPIECE

K-Number: K944512 · 1994-11-02

ApplicantMonaghan Medical Corp.
Decision Date1994-11-02
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRUZONE PFM DISPOSABLE MOUTHPIECE 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 1994-11-02 under 510(k) number K944512. 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 TRUZONE PFM DISPOSABLE MOUTHPIECE?

TRUZONE PFM DISPOSABLE MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K944512.

When did TRUZONE PFM DISPOSABLE MOUTHPIECE receive FDA 510(k) clearance?

TRUZONE PFM DISPOSABLE MOUTHPIECE received FDA 510(k) clearance on 1994-11-02, under 510(k) number K944512.

Who is the listed applicant for TRUZONE PFM DISPOSABLE MOUTHPIECE?

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 TRUZONE PFM DISPOSABLE MOUTHPIECE?

The FDA product code for TRUZONE PFM DISPOSABLE MOUTHPIECE 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.

K123945STRIVE DUAL ZONE PEAK FLOW METERK031514MODIFICATION TO TRUPEAK PEAK FLOW METERK023097TRUEZONE PEAK FLOW METERK012939AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBERK991212MODIFICATION TO TRUZONE PEAK FLOW METERK964130AEROGEAR ASTHMA ACTION KIT

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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.K893791BREATHING MOUTHPIECEDiemolding Corp.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, Inc.K862788MP-4400 MOUTHPIECE-FLANGE SEALMedipart Jerry Alexander

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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