THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT— 510(k) K962749

Name: FDA 510(k) clearance K962749
Creator: U.S. Food and Drug Administration
Published: 1996-10-10

Substantially Equivalent

Diemolding Corp.

FDA 510(k) clearance K962749 for THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT, Substantially Equivalent on 1996-10-10. Applicant: Diemolding Corp.. Device class: 2.

Clearance details

Applicant: Diemolding Corp.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1996-07-15
Decision date: 1996-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canastota, 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 Diemolding Corp.

view all

K961455 — MEDSHIELD/AEROCHAMBER1996-07-25
K902713 — ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS1990-07-25
K902114 — CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR1990-07-18
K900754 — RESPIREX 21990-03-15
K893791 — BREATHING MOUTHPIECE1989-06-23

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