Cleared Traditional

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

K232015 · Atmos Medizintechnik GmbH & Co. KG · Ear, Nose, Throat

Aug 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K232015 is an FDA 510(k) clearance for the ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0), a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Atmos Medizintechnik GmbH & Co. KG (Lenzkirch, DE). The FDA issued a Cleared decision on August 3, 2023, 28 days after receiving the submission on July 6, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K232015 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2023
Decision Date	August 03, 2023
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).