Cardiostat 3 Recorder
510(k) K851044
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851044 | Date26 Jun 1985 | 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- Withdrawn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
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Cardiostat 3 Recorder is a device used in the field of cardiovascular health. It is classified under the product code DPS. The device is substantially equivalent and has been reviewed by the Cardiovascular advisory committee.
The Cardiostat 3 Recorder is supplied by Siemens Elema AB and has been cleared under the FDA 510K authorization, with the clearance number K851044. The device was cleared on June 26, 1985.
Other devices from Siemens Elema AB
Questions
AI-generated answers, 28 Sep 2026
What is the Cardiostat 3 Recorder used for?
The Cardiostat 3 Recorder is used in the field of cardiovascular health to monitor heart activity.
Is the Cardiostat 3 Recorder cleared by the FDA?
Yes, the Cardiostat 3 Recorder has been cleared under the FDA 510K authorization with clearance number K851044.
Who manufactures the Cardiostat 3 Recorder?
The Cardiostat 3 Recorder is supplied by Siemens Elema AB.