Stanford Assoc., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Stanford Assoc., Inc. makes
Stanford Associates, Inc. manufactures electrocardiogram (ECG) recording devices, including heart rate computer strip chart recorders and standalone heart rate computers. These devices are designed for clinical use to capture and display cardiac rhythm data for diagnostic purposes.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) premarket notification database. The manufacturer is based in the United States.
Catalogue
Heart Rate Computer Strip Chart Ref K791927
Regimes: 510(k) Registry: 510(k)Heart Rate Computer Ref K791862
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stanford Assoc., Inc. have in the registry?
The registry currently lists 2 devices for Stanford Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stanford Assoc., Inc.'s devices?
Among its 2 most recently registered devices, Stanford Assoc., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Stanford Assoc., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Stanford Assoc., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stanford Assoc., Inc. in the registry?
The most recently registered devices listed for Stanford Assoc., Inc. include HEART RATE COMPUTER STRIP CHART and HEART RATE COMPUTER.