Amer. Bentley Hemofilter Holder HFH-1
FDA 510(k) K843504 · American Bentley
510(k) numberK843504
Submission
- Device name
- Amer. Bentley Hemofilter Holder HFH-1
- Applicant
- American Bentley
Irvine, CA, US - Received
- September 6, 1984
- Decision date
- October 18, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKI – Set, Dialyzer Holder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Amer. Bentley Hemofilter Holder HFH-1 cleared by the FDA?
Amer. Bentley Hemofilter Holder HFH-1 (K843504) received a 510(k) decision of Substantially Equivalent on October 18, 1984, 42 days after the submission was received.
What is the product code of K843504?
The FDA product code is FKI – Set, Dialyzer Holder, a Class II (moderate risk) device regulated under 21 CFR 876.5820.