Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005527904

FEI Number

3005527904

Entity Name

ATMOS INC.

City/State/Country

Exton, PA, US

Establishment Address

29 Dowlin Forge Road, Exton, PA 19341, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ATMOS MEDIZINTECHNIK GMBH & CO. KG (Owner Number: 8010573)

Owner / Operator Contact Address

LUDWIG-KEGEL-STR. 16, LENZKIRCH, DE-BW 79853, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ATMOS i View 31 ATMOS i View 21 ATMOS i View 31 PRO ATMOS i View 21 PRO ATMOS SURGICAL CHAIRS ATMOS Strobo 21 LED ATMOS STROBOSCOPES ATMOS Scope ATMOS Scope Basic Varioair ATMOS VideoScope PED ATMOS Video-Nasopharyngoscope, 3.9 mm ATMOS VideoScope ATMOS Nasopharyngoscope PED ATMOS iQam ATMOS i View 21 COLPO ATMOS i View 31 COLPO ATMOS OTOSCOPES ATMOS S 201 Thorax ATMOS ENT EXAMINATION AND TREATMENT UNITS ATMOS Scope (507.7000); ATMOS Scope Pro (507.7050); ATMOS Scope iPrime (507.7060) ATMOS EXAMINATION LIGHTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2003-07-16
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2003-07-24
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	1988-10-25
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-04-13
KHH	Stimulator, Caloric-Air	Ear, Nose, Throat	Class 1	874.1800	2002-06-10
EQN	Laryngoscope, Nasopharyngoscope	Ear, Nose, Throat	Class 2	874.4760	2020-12-15
FWG	Camera, Television, Endoscopic, With Audio	General, Plastic Surgery	Class 1	878.4160	2003-07-16
PTZ	Colposcope (And Colpomicroscope), Exempt	Obstetrics/Gynecology	Class 2	884.1630	2017-07-27
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2003-07-16
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2011-05-05
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	Class 1	874.5300	1991-01-24
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-08-08
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2003-07-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATMOS MEDIZINTECHNIK GMBH & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8010573	ATMOS MEDIZINTECHNIK GMBH & CO. KG	LENZKIRCH Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

Similar Registrations

Registration Number	Establishment Name	Location
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3025436467	GAVIN BIOTECHNOLOGY CO.,LTD	Jinzhong Shanxi, CN
3013351723	SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD.	shenzhen Guangdong, CN
3013154160	Suzhou Semorr Medical Technology Co.,Ltd.	Suzhou Jiangsu, CN
3001644167	Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005527904. Last updated year: 2026. Please use registration number 3005527904 when referencing this establishment in official correspondence.