DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS— 510(k) K951491

Name: FDA 510(k) clearance K951491
Creator: U.S. Food and Drug Administration
Published: 1995-04-24

Substantially Equivalent

Dale Medical Products, Inc.

FDA 510(k) clearance K951491 for DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS, Substantially Equivalent on 1995-04-24. Applicant: Dale Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Dale Medical Products, Inc.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1995-03-31
Decision date: 1995-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainville, MA, 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
K950930 — TRACHE-TITE1995-03-22
K950318 — FLEX BLUE1995-02-13

More clearances from Dale Medical Products, Inc.

view all

K082241 — THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H841047512008-10-30
K994300 — NASOGASTRIC TUBE HOLDER, MODEL 1602000-02-10
K961693 — DALE GASTROSTOMY TUBE HOLDER1996-07-30
K914245 — DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)1991-12-09
K905231 — DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.1991-01-14

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.