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FDA 510(k)

SAFE-T-SHIELD MOUTHPIECE

K-Number: K865093 · 1987-01-15

ApplicantMedi Nuclear Corp., Inc.
Decision Date1987-01-15
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SAFE-T-SHIELD MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Medi Nuclear Corp., Inc.. It received FDA 510(k) clearance on 1987-01-15 under 510(k) number K865093. 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 SAFE-T-SHIELD MOUTHPIECE?

SAFE-T-SHIELD MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1987-01-15. The listed applicant is Medi Nuclear Corp., Inc.. The 510(k) number is K865093.

When did SAFE-T-SHIELD MOUTHPIECE receive FDA 510(k) clearance?

SAFE-T-SHIELD MOUTHPIECE received FDA 510(k) clearance on 1987-01-15, under 510(k) number K865093.

Who is the listed applicant for SAFE-T-SHIELD MOUTHPIECE?

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

What is the FDA product code for SAFE-T-SHIELD MOUTHPIECE?

The FDA product code for SAFE-T-SHIELD MOUTHPIECE is BYP.

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Other records listing Medi Nuclear Corp., 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.

K082541HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEMK080969HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510K080657NEB-90 LARGE VOLUME MEDICATION NEBULIZERK915075NEBULIZER (DIRECT PATIENT INTERFACE)K865107AERO-VENT AEROSOL UNITK863996MODEL XE-103 XENON/MASTER II

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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.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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