RESPIRONICS SIMPLYCLEAR DEVICE— 510(k) K122111

Name: FDA 510(k) clearance K122111
Creator: U.S. Food and Drug Administration
Published: 2012-12-31

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K122111 for RESPIRONICS SIMPLYCLEAR DEVICE, Substantially Equivalent on 2012-12-31. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Respironics, Inc.
Product code: Code SDT
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Date received: 2012-07-17
Decision date: 2012-12-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SDT

view all

K241091 — SIMEOX 200 Airway Clearance Device2024-12-23
K133057 — VIBRALUNG ACOUSTICAL PERCUSSOR2014-05-23

More clearances from Respironics, Inc.

view all

K243394 — AF531 Oro-Nasal SE Face Mask2024-12-30
K231313 — Therapy Mask 3100 NC/SP2023-07-28
K210844 — DreamWear Silicone Pillows Mask2021-08-24
K210386 — Magneto Nasal Mask2021-07-12
K202142 — Sleepware G32020-10-29

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