FDA Registration
Active
🇺🇸 United States
ATMOS INC.
Reg #: 3005527904
·
FEI: 3005527904
·
Expires 2026
Products
14
Proprietary Names
29
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- ATMOS INC.
- Registration Number
- 3005527904
- FEI Number
- 3005527904
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 29 Dowlin Forge Road
- City
- Exton
- State
- PA
- ZIP
- 19341
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143673
Owner / Operator
- Firm Name
- ATMOS MEDIZINTECHNIK GMBH & CO. KG
- Operator Number
- 8010573
- Address
- LUDWIG-KEGEL-STR. 16
- City
- LENZKIRCH
- State
- Baden-Wurttemberg
- Postal Code
- 79853
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2003-07-16 |
| Chair, Surgical, Ac-Powered | GBB | Class 1 | General, Plastic Surgery | No | 2003-07-24 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 1988-10-25 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2016-04-13 |
| Stimulator, Caloric-Air | KHH | Class 1 | Ear, Nose, Throat | No | 2002-06-10 |
| Laryngoscope, Nasopharyngoscope | EQN | Class 2 | Ear, Nose, Throat | No | 2020-12-15 |
| Camera, Television, Endoscopic, With Audio | FWG | Class 1 | General, Plastic Surgery | No | 2003-07-16 |
| Colposcope (And Colpomicroscope), Exempt | PTZ | Class 2 | Obstetrics/Gynecology | No | 2017-07-27 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2003-07-16 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2011-05-05 |
| Unit, Examining/Treatment, Ent | ETF | Class 1 | Ear, Nose, Throat | No | 1991-01-24 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2003-07-16 |
| Stimulator, Caloric-Water | ETP | Class 1 | Ear, Nose, Throat | No | 1980-12-22 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2003-07-16 |
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
Hygrotherm plus
Variotherm plus
ATMOS LIGHT SOURCES
ATMOS C 361
ATMOS C 451
ATMOS C 051
ATMOS C 051 Thorax
Establishment Types
Repack or Relabel Medical Device