Data / Medical devices / Germany / Honeywell Healthcare Solutions GmbH (formerly EnviteC)
Honeywell Healthcare Solutions GmbH (formerly EnviteC): FDA-registered device maker in WISMAR Mecklenburg-Western Pomerania, Germany, 3 510(k) clearances
Honeywell Healthcare Solutions GmbH (formerly EnviteC) is registered with the FDA (registration 9617268) in WISMAR Mecklenburg-Western Pomerania, Germany. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 23, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617268
- FEI number
- 1000352675
- Address
- Alter Holzhafen 18, WISMAR Mecklenburg-Western Pomerania, Germany, 23966
- Owner or operator
- Honeywell Healthcare Solutions GmbH (formerly EnviteC) (10060527)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- May 23, 2019
- Registered through
- 2026
- Brand names listed
- 6050-0004-110, AlcoQuant 6020 Plus, EnviteC Medical Oxygen Sensors, Flow Sensor SpiroQuant, Flow Sensor SpiroQuant A+, Flow Sensor SpiroQuant H, MOX2, MOX3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transducer, Gas Flow | BXP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2013 | K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | CCL | Substantially Equivalent | Envitec-Wismar GmbH | accessdata.fda.gov |
| November 25, 2008 | K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | CCL | Substantially Equivalent | Envitec-Wismar GmbH | accessdata.fda.gov |
| July 15, 2004 | K041773 | OXYGEN MEDICELS, CITICELS | CCL | Substantially Equivalent | City Technology Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Gas, Oxygen, Gaseous-Phase
- All makers of Transducer, Gas Flow
- All makers of Devices, Breath Trapping, Alcohol
Updated January 23, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.