Oregon Scientific
510(k) K151415
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151415 | Date21 Oct 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Oregon Scientific is a device classified under the product code DXN, described as substantially equivalent by the FDA. It falls under the advisory committee description of Cardiovascular. The device has been assigned a k number, K151415.
The Oregon Scientific device is supplied by Idt Technology Limited, with its headquarters in Hong Kong. The device has received FDA 510K authorization, indicating substantial equivalence. The device is associated with a traditional clearance type, and its specifications are outlined in the provided data.
Other devices from Idt Technology Limited
Questions
AI-generated answers, 21 Sep 2026
What is the Oregon Scientific device used for?
The Oregon Scientific device is used for cardiovascular purposes, as described by the advisory committee.
What type of clearance does the Oregon Scientific device have?
The Oregon Scientific device has received traditional FDA 510K authorization, indicating substantial equivalence.
Who is the manufacturer of the Oregon Scientific device?
The Oregon Scientific device is supplied by Idt Technology Limited, with its headquarters in Hong Kong.