Bag Decanter
FDA 510(k) K972134 · Remington Medical, Inc.
510(k) numberK972134
Submission
- Device name
- Bag Decanter
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- June 6, 1997
- Decision date
- August 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Bag Decanter cleared by the FDA?
Bag Decanter (K972134) received a 510(k) decision of Substantially Equivalent on August 26, 1997, 81 days after the submission was received.
What is the product code of K972134?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.