Minivason 9
FDA 510(k) K800097 · Kt Medical, Inc.
510(k) numberK800097
Submission
- Device name
- Minivason 9
- Applicant
- Kt Medical, Inc.
Mchenry, IL, US - Received
- January 14, 1980
- Decision date
- February 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Multigon Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K800653 | Sinvision Linear Array Real TimeDXK · Traditional | 07/21/1980SE |
| K800652 | Model E03 Echo-OpthalmoscopeIYO · Traditional | 05/14/1980SE |
| K800101 | 4200 Me EchoencephalographIYO · Traditional | 05/02/1980SE |
| K800092 | Combison ComputerDQK · Traditional | 04/08/1980SE |
| K800100 | 7200 Ma Echo-OphthalmoscopeIYO · Traditional | 02/21/1980SE |
| K800099 | Intracula IIIYO · Traditional | 02/21/1980SE |
| K800098 | Minifeton 200KNG · Traditional | 02/11/1980SE |
| K800096 | Ambivason DR-200JAF · Traditional | 02/11/1980SE |
| K800095 | MGD-3KNG · Traditional | 02/11/1980SE |
| K800094 | Combison 200 & Combison 202IYO · Traditional | 02/11/1980SE |
Questions and answers
When was Minivason 9 cleared by the FDA?
Minivason 9 (K800097) received a 510(k) decision of Substantially Equivalent on February 11, 1980, 28 days after the submission was received.
What is the product code of K800097?
The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.