BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE— 510(k) K991300

Name: FDA 510(k) clearance K991300
Creator: U.S. Food and Drug Administration
Published: 1999-07-12

Substantially Equivalent

Dhd Healthcare Corp.

FDA 510(k) clearance K991300 for BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE, Substantially Equivalent on 1999-07-12. 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: 1999-04-16
Decision date: 1999-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wampsville, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BWF

view all

K241152 — InSee2025-08-21
K233855 — AllPEP2024-02-02
K221058 — LungTrainer (MD2 & MD3)2023-07-05
K222018 — Breathe+2023-06-02
K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser2022-10-25

More clearances from Dhd Healthcare Corp.

view all

K040718 — TRUST2004-04-02
K002768 — ACAPELLA2000-12-05
K003146 — CLINIFLO INCENTIVE SPIROMETER2000-11-21
K991561 — ROADRUNNER, PEP THERAPY DEVICE1999-11-10
K983467 — THERAPEP1999-04-02

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