Medevice V-80 Vacuum Pump
FDA 510(k) K840952 · Berkeley Medevices
510(k) numberK840952
Submission
- Device name
- Medevice V-80 Vacuum Pump
- Applicant
- Berkeley Medevices
Walker, MI, US - Received
- March 5, 1984
- Decision date
- March 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
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| K983181 | CytoprepHHI · Traditional | Cytoprep Inc. Est. | 11/16/1998SE |
| K931205 | Medi Vac Specimen Collector and TransporterHHI · Traditional | Baxter Healthcare Corp | 03/15/1994SE |
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| K900641 | Cannula, Suction UterineHHI · Traditional | Williams Specialty Products, Inc. | 03/30/1990SE |
| K900642 | Swivel AdapterHHI · Traditional | Williams Specialty Products, Inc. | 03/19/1990SE |
| K880734 | Scented or Scented Deodorized Menstrual PadsHHI · Traditional | Personal Products Co. | 04/25/1988SE |
| K873552 | Cannula and General Purpose AspiratorHHI · Traditional | Cosmedtech, Inc. | 11/25/1987SE |
| K870574 | Cosmedtech General AspiratorHHI · Traditional | Cosmedtech, Inc. | 03/05/1987SE |
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Questions and answers
When was Medevice V-80 Vacuum Pump cleared by the FDA?
Medevice V-80 Vacuum Pump (K840952) received a 510(k) decision of Substantially Equivalent on March 30, 1984, 25 days after the submission was received.
What is the product code of K840952?
The FDA product code is HHI – System, Abortion, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.