THE BREATHER— 510(k) K944412

Substantially Equivalent

Pal Medical, Inc.

FDA 510(k) clearance K944412 for THE BREATHER, Substantially Equivalent on 1995-04-26. Applicant: Pal Medical, Inc.. Device class: 2.

Clearance details

Applicant: Pal Medical, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1994-09-08
Decision date: 1995-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BWF

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

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