Ckg 8800
510(k) K823215
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823215 | Date24 Nov 1982 | 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- Withdrawn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
- DSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2770
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Ckg 8800 is a Plethysmograph, Impedance, which is a device used in the medical specialty of Cardiovascular. It is classified as a class 2 device.
The device is supplied with a product code of DSB and is regulated under regulation number 870.2770. It has been cleared by the FDA with a 510K number of K823215, with a decision date of 1982-11-24. The device is intended for use in a clinical setting, with no information provided on its sterility, single-use or reusable status, MRI safety, or storage requirements.
Other devices from Cardio Kinetics, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the CKG 8800 used for?
The CKG 8800 is used in the medical specialty of Cardiovascular, specifically as a Plethysmograph, Impedance device.
Is the CKG 8800 sterile or reusable?
The device's sterility, single-use or reusable status is not provided in the available information.
What is the regulatory classification of the CKG 8800?
The CKG 8800 is classified as a class 2 device, regulated under regulation number 870.2770, and has been cleared by the FDA with a 510K number of K823215.