Silberg T.P.S., Tissue Preparation System, Model Me 800
FDA 510(k) K023083 · Mettler Electronics Corp.
510(k) numberK023083
Submission
- Device name
- Silberg T.P.S., Tissue Preparation System, Model Me 800
- Applicant
- Mettler Electronics Corp.
Anaheim, CA, US - Received
- September 17, 2002
- Decision date
- February 28, 2003
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Abbreviated 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Silberg T.P.S., Tissue Preparation System, Model Me 800 cleared by the FDA?
Silberg T.P.S., Tissue Preparation System, Model Me 800 (K023083) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on February 28, 2003, 164 days after the submission was received.
What is the product code of K023083?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.