Centry 2 Ultrafiltration Control Kit, #018762-002
FDA 510(k) K881062 · Cobe Laboratories, Inc.
510(k) numberK881062
Submission
- Device name
- Centry 2 Ultrafiltration Control Kit, #018762-002
- Applicant
- Cobe Laboratories, Inc.
Lakewood, CO, US - Received
- March 14, 1988
- Decision date
- April 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJB – Detector, Dialysate Level
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJB
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Questions and answers
When was Centry 2 Ultrafiltration Control Kit, #018762-002 cleared by the FDA?
Centry 2 Ultrafiltration Control Kit, #018762-002 (K881062) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 38 days after the submission was received.
What is the product code of K881062?
The FDA product code is FJB – Detector, Dialysate Level, a Class II (moderate risk) device regulated under 21 CFR 876.5820.