Medi Vac Specimen Collector and Transporter
FDA 510(k) K931205 · Baxter Healthcare Corp
510(k) numberK931205
Submission
- Device name
- Medi Vac Specimen Collector and Transporter
- Applicant
- Baxter Healthcare Corp
Deerfield, IL, US - Received
- March 9, 1993
- Decision date
- March 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HHI – System, Abortion, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5070
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Medi Vac Specimen Collector and Transporter cleared by the FDA?
Medi Vac Specimen Collector and Transporter (K931205) received a 510(k) decision of Substantially Equivalent on March 15, 1994, 371 days after the submission was received.
What is the product code of K931205?
The FDA product code is HHI – System, Abortion, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.