Ultra PVD
FDA 510(k) K912925 · Advanced Medical Products, Inc.
510(k) numberK912925
Submission
- Device name
- Ultra PVD
- Applicant
- Advanced Medical Products, Inc.
Washington, DC, US - Received
- July 3, 1991
- Decision date
- June 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K242487 | Laminar P1 (LDH-HW-001)JAF · Traditional | Laminar Digital Health, Inc. | 12/13/2024SE |
| K141657 | THD RevolutionJAF · Traditional | Thd Spa | 02/24/2015SE |
| K110628 | SimpleabiJAF · Traditional | Newman Medical | 05/12/2011SE |
| K093393 | Lifedop Model 300ABIJAF · Traditional | Summit Doppler Systems, Inc. | 12/24/2009SE |
| K090009 | THD Slide OneJAF · Special | Thd Spa | 01/28/2009SE |
| K081429 | THD SlideJAF · Traditional | Thd Spa | 07/30/2008SE |
| K070815 | THDJAF · Traditional | G.F. S.R.L. | 06/20/2007SE |
| K063600 | Vista AvsJAF · Traditional | Summit Doppler Systems, Inc. | 12/19/2006SE |
| K060064 | StethofluxJAF · Traditional | Odvi | 04/10/2006SE |
| K052067 | Doppler Guided Proctoscope, Model 500HJAF · Traditional | Multigon Industries, Inc. | 08/29/2005SE |
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| K921426 | Ultra PciIYO · Traditional | 10/05/1992SE |
| K915658 | Spectra ECGLOS · Traditional | 06/10/1992SE |
| K896103 | Micro FL 7400 Ambulatory Holter/Bp MonitorDSI · Traditional | 01/18/1990SE |
| K896102 | Micro FD 7000 Ambulatory Blood Pressure MonitorDXN · Traditional | 01/18/1990SE |
| K881905 | Model Micro Si Ambulatory ECG MonitorDSI · Traditional | 08/02/1988SE |
| K872508 | Model Micro Fd+ Ambulatory ECG MonitorDSH · Traditional | 09/25/1987SE |
| K870538 | Model 192 PrinterDSF · Traditional | 04/23/1987SE |
| K870537 | Model Micro ST Ambulatory ECG MonitorDSH · Traditional | 04/23/1987SE |
Questions and answers
When was Ultra PVD cleared by the FDA?
Ultra PVD (K912925) received a 510(k) decision of Substantially Equivalent on June 18, 1992, 351 days after the submission was received.
What is the product code of K912925?
The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.