Coil Dialysis, Models DM-360 and DM-360-
FDA 510(k) K790382 · Estracorporeal, Inc.
510(k) numberK790382
Submission
- Device name
- Coil Dialysis, Models DM-360 and DM-360-
- Applicant
- Estracorporeal, Inc.
Mchenry, IL, US - Received
- February 27, 1979
- Decision date
- May 2, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKD – Canister, Coil
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
More from Estracorporeal, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915130 | Mat Membrane Autotransfusion SystemCAC · Traditional | 02/22/1993SE |
Questions and answers
When was Coil Dialysis, Models DM-360 and DM-360- cleared by the FDA?
Coil Dialysis, Models DM-360 and DM-360- (K790382) received a 510(k) decision of Substantially Equivalent on May 2, 1979, 64 days after the submission was received.
What is the product code of K790382?
The FDA product code is FKD – Canister, Coil, a Class II (moderate risk) device regulated under 21 CFR 876.5820.