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FDA 510(k)

MOUTHPIECE, BREATHING

K-Number: K810793 · 1981-05-05

ApplicantDhd Medical Products Div. Diemolding Corp.
Decision Date1981-05-05
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTHPIECE, BREATHING is the device name listed in this FDA 510(k) record. The listed applicant is Dhd Medical Products Div. Diemolding Corp.. It received FDA 510(k) clearance on 1981-05-05 under 510(k) number K810793. 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 MOUTHPIECE, BREATHING?

MOUTHPIECE, BREATHING is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Dhd Medical Products Div. Diemolding Corp.. The 510(k) number is K810793.

When did MOUTHPIECE, BREATHING receive FDA 510(k) clearance?

MOUTHPIECE, BREATHING received FDA 510(k) clearance on 1981-05-05, under 510(k) number K810793.

Who is the listed applicant for MOUTHPIECE, BREATHING?

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

What is the FDA product code for MOUTHPIECE, BREATHING?

The FDA product code for MOUTHPIECE, BREATHING is BYP.

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Other records listing Dhd Medical Products Div. 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.

K883988NON-REBREATHING TEE PIECE (NRTP)K881935MICROCIRRUS MEDICAL NEBULIZERK881178CUFFCHECKK873498INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBINGK874047ASTHMAKITK873447DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR

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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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