Smartcell Processing System
FDA 510(k) K983022 · Harvest Technologies, LLC
510(k) numberK983022
Submission
- Device name
- Smartcell Processing System
- Applicant
- Harvest Technologies, LLC
Norwell, MA, US - Received
- August 31, 1998
- Decision date
- April 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Smartcell Processing System cleared by the FDA?
Smartcell Processing System (K983022) received a 510(k) decision of Substantially Equivalent on April 2, 1999, 214 days after the submission was received.
What is the product code of K983022?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.