ENDO TRACHEA TUBE FIXATION— 510(k) K924551

Name: FDA 510(k) clearance K924551
Creator: U.S. Food and Drug Administration
Published: 1992-12-08

Substantially Equivalent

M. Imonti and Associates Inc.,

FDA 510(k) clearance K924551 for ENDO TRACHEA TUBE FIXATION, Substantially Equivalent on 1992-12-08. Applicant: M. Imonti and Associates Inc.,. Device class: 1.

Clearance details

Applicant: M. Imonti and Associates Inc.,
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1992-09-09
Decision date: 1992-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBH

view all

K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM2014-09-24
K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/2801997-01-28
K942529 — HCI TUBE STABILIZER1995-06-14
K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS1995-04-24
K950930 — TRACHE-TITE1995-03-22

More clearances from M. Imonti and Associates Inc.,

view all

K950800 — PRO-PAK FOR OMS DIPLOMATE1995-05-22
K950799 — PRO-VIT1995-04-28
K933627 — PHACOFRAGMENTOR TIP1994-01-25
K933503 — PRO-PHACO HANDPIECE1994-01-06
K905766 — DRAINAGE TUBE RESTRAINT/WOUND COVER1991-03-06

Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.