FDA device listing
ATMOS i View 21 COLPO,ATMOS i View 31 COLPO
FDA device listing 2032354262 · ATMOS MEDIZINTECHNIK GMBH & CO. KG
Key facts
| Proprietary names | ATMOS i View 21 COLPO,ATMOS i View 31 COLPO |
|---|---|
| Owner/operator | ATMOS MEDIZINTECHNIK GMBH & CO. KG |
| Owner/operator number | 8010573 |
| Product codes | PTZ |
| Device names | PTZ - Colposcope (And Colpomicroscope), Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.1630 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | ATMOS INC., ATMOS MEDIZINTECHNIK GMBH & CO. KG |
| Establishment registrations | 8010573, 3005527904 |
| FEI numbers | 3003169291, 3005527904 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database