Sagatech Electronics, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sagatech Electronics, Inc. makes
Sagatech Electronics, Inc. manufactures the SNORE SAT RECORDER (Model SS41), a device designed to record and analyze snoring patterns for diagnostic purposes.
The SNORE SAT RECORDER is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Snore Sat Recorder, Model SS41 Ref K002159
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Sagatech Electronics, Inc., initiated on 2008-05-08. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 8 May 2008 Z-1725-2013 Class II Terminated The outer jacket is receding away from the black sensor prematurely.
Frequently asked questions
How many devices does Sagatech Electronics, Inc. have in the registry?
The registry currently lists 1 device for Sagatech Electronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sagatech Electronics, Inc.'s devices?
Among its 1 most recently registered device, Sagatech Electronics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Sagatech Electronics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sagatech Electronics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sagatech Electronics, Inc.?
FDA recall records list 1 recall initiated by Sagatech Electronics, Inc., the most recent initiated on 8 May 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sagatech Electronics, Inc. in the registry?
The most recently registered devices listed for Sagatech Electronics, Inc. include SNORE SAT RECORDER, MODEL SS41.