ACAPELLA— 510(k) K002768

Substantially Equivalent

Dhd Healthcare Corp.

FDA 510(k) clearance K002768 for ACAPELLA, Substantially Equivalent on 2000-12-05. Applicant: Dhd Healthcare Corp.. Device class: 2.

Clearance details

Applicant: Dhd Healthcare Corp.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2000-09-06
Decision date: 2000-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wampsville, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K002768

K-number listed on FDA's recall record

Z-0874-2021 — Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.Class II·Terminated·Smiths Medical ASD Inc.·20201221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002768.

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