Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010573

FEI Number

3003169291

Entity Name

ATMOS MEDIZINTECHNIK GMBH & CO. KG

City/State/Country

LENZKIRCH Baden-Wurttemberg, DE

Establishment Address

LUDWIG-KEGEL-STRASSE 16, LENZKIRCH Baden-Wurttemberg 79853, DE

Establishment Type(s)

Manufacture 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

Varioair ATMOS EXAMINATION LIGHTS ATMOS Scope (507.7000); ATMOS Scope Pro (507.7050); ATMOS Scope iPrime (507.7060) ATMOS VideoScope PED ATMOS Video-Nasopharyngoscope, 3.9 mm ATMOS VideoScope ATMOS Nasopharyngoscope PED ATMOS Strobo 21 LED ATMOS STROBOSCOPES ATMOS C 361 ATMOS C 451 Hygrotherm plus Variotherm plus ATMOS LIGHT SOURCES ATMOS Scope ATMOS Scope Basic ATMOS C 051 ATMOS C 051 Thorax ATMOS SURGICAL CHAIRS ATMOS ENT EXAMINATION AND TREATMENT UNITS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHH	Stimulator, Caloric-Air	Ear, Nose, Throat	Class 1	874.1800	2002-06-10
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2003-07-16
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-08-08
EQN	Laryngoscope, Nasopharyngoscope	Ear, Nose, Throat	Class 2	874.4760	2020-12-15
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	1988-10-25
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2009-03-06
ETP	Stimulator, Caloric-Water	Ear, Nose, Throat	Class 1	874.1800	1980-12-22
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2003-07-16
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-04-13
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2025-03-19
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2003-07-24
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	Class 1	874.5300	1991-01-24

Official Correspondent

Abdulaziz Abdunasimov

US Agent Details

Nathan Pohlit Business: ATMOS Inc. Email: npohlit@atmosmed.com Phone: (610) 3517221

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
3005527904	ATMOS INC.	Exton, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010573. Last updated year: 2026. Please use registration number 8010573 when referencing this establishment in official correspondence.