Medac, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Medac, Inc. makes
Medac, Inc. manufactures electrographic monitoring devices, including external pacing electrodes with low and high impedance, disposable gel electrodes for defibrillation and pacing, and non-invasive external pacemakers such as the ETP 180E, ETP 300, and PACE 10. Their portfolio also includes a 360D DC defibrillator and ECG monitors with transcutaneous pacing capabilities, such as the 300M.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Medac, Inc. is based in the United States.
Catalogue
Monitor, Electrographic Ref K874319
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Etp 180E Non-Invasive External Pacemaker Ref K864988
Regimes: 510(k) Registry: 510(k)Etp 300 Non-Invasive External Pacemaker Ref K864986
Regimes: 510(k) Registry: 510(k)Etp 180A Non-Invasive External Pacemaker Ref K864989
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
360D Dc Defibrillator Ref K874091
Regimes: 510(k) Registry: 510(k)Pace 10 Non-Invasive External Pacemaker Ref K871176
Regimes: 510(k) Registry: 510(k)300M Ecg Monitro/Transcutaneous Pacemaker Ref K874090
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medac, Inc. have in the registry?
The registry currently lists 10 devices for Medac, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medac, Inc.'s devices?
Among its 10 most recently registered devices, Medac, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Medac, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Medac, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medac, Inc. in the registry?
The most recently registered devices listed for Medac, Inc. include MONITOR, ELECTROGRAPHIC, DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE, ETP 180E NON-INVASIVE EXTERNAL PACEMAKER and ETP 300 NON-INVASIVE EXTERNAL PACEMAKER.