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FDA 510(k)

MOUTHPIECE M-187

K-Number: K790933 · 1979-05-21

ApplicantMem Medical, Inc.
Decision Date1979-05-21
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTHPIECE M-187 is the device name listed in this FDA 510(k) record. The listed applicant is Mem Medical, Inc.. It received FDA 510(k) clearance on 1979-05-21 under 510(k) number K790933. 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 M-187?

MOUTHPIECE M-187 is a medical device that received FDA 510(k) clearance on 1979-05-21. The listed applicant is Mem Medical, Inc.. The 510(k) number is K790933.

When did MOUTHPIECE M-187 receive FDA 510(k) clearance?

MOUTHPIECE M-187 received FDA 510(k) clearance on 1979-05-21, under 510(k) number K790933.

Who is the listed applicant for MOUTHPIECE M-187?

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

What is the FDA product code for MOUTHPIECE M-187?

The FDA product code for MOUTHPIECE M-187 is BYP.

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Other records listing Mem Medical, Inc. 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.

K791907RETARD VALVE 3-STACK #M-515K791909IMV BUSHING #M-513K791913IMV MANIFOLD #M-506K791904IMV W/BAG & HOSES #M-509K791908RETARD VALVE 3-STACK #M-514K791912IMV FOR MONITORING #M-510

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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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