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FDA 510(k)

ENDO TRACHEA TUBE FIXATION

K-Number: K924551 · 1992-12-08

ApplicantM. Imonti and Associates Inc.,
Decision Date1992-12-08
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENDO TRACHEA TUBE FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is M. Imonti and Associates Inc.,. It received FDA 510(k) clearance on 1992-12-08 under 510(k) number K924551. The device is classified under product code CBH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO TRACHEA TUBE FIXATION?

ENDO TRACHEA TUBE FIXATION is a medical device that received FDA 510(k) clearance on 1992-12-08. The listed applicant is M. Imonti and Associates Inc.,. The 510(k) number is K924551.

When did ENDO TRACHEA TUBE FIXATION receive FDA 510(k) clearance?

ENDO TRACHEA TUBE FIXATION received FDA 510(k) clearance on 1992-12-08, under 510(k) number K924551.

Who is the listed applicant for ENDO TRACHEA TUBE FIXATION?

The FDA 510(k) record lists M. Imonti and Associates Inc., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO TRACHEA TUBE FIXATION?

The FDA product code for ENDO TRACHEA TUBE FIXATION is CBH.

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Other records listing M. Imonti and Associates 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.

K950800PRO-PAK FOR OMS DIPLOMATEK950799PRO-VITK933627PHACOFRAGMENTOR TIPK933503PRO-PHACO HANDPIECEK905766DRAINAGE TUBE RESTRAINT/WOUND COVER

Related Devices (Code: CBH)

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.

K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.K942529HCI TUBE STABILIZERHealth Care Contracts, Inc.K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSDale Medical Products, Inc.K950930TRACHE-TITEThe Varner Group, Inc.K950318FLEX BLUEKing Systems Corp.K942395ENDOTRACHEAL TUBE HOLDERS.T.I. Medical Products Corp.

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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