Sabratek Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Sabratek Corp. makes
Sabratek Corp. makes ambulatory patient monitors, infusion pumps, and patient home management systems. Specific products include the APM-2000 ambulatory patient monitor with transcutaneous temperature monitoring, Sabrasil sets, and volumetric infusion pumps such as the 6060 Homerun, 3030, and 4040 models.
The devices are classified as Class II and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Sabratek Sabsil Sets Ref K944293
Regimes: 510(k) Registry: 510(k)Sabratek 6060 Homerun Volumetric Infusion Pump Ref K941984
Regimes: 510(k) Registry: 510(k)Sabratek 3030 Infusion Pump Ref K914589
Regimes: 510(k) Registry: 510(k)Sabratek 4040 Infusion Pump Ref K980751
Regimes: 510(k) Registry: 510(k)Sabratek Patient Home Management System Ref K980619
Regimes: 510(k) Registry: 510(k)3030 Infusion Pump Ref K955258
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sabratek Corp. have in the registry?
The registry currently lists 7 devices for Sabratek Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sabratek Corp.'s devices?
Among its 7 most recently registered devices, Sabratek Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Sabratek Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Sabratek Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sabratek Corp. in the registry?
The most recently registered devices listed for Sabratek Corp. include SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR, SABRATEK SABSIL SETS, SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP and SABRATEK 3030 INFUSION PUMP.