Lifedop Model 300ABI
FDA 510(k) K093393 · Summit Doppler Systems, Inc.
510(k) numberK093393
Submission
- Device name
- Lifedop Model 300ABI
- Applicant
- Summit Doppler Systems, Inc.
Golden, CO, US - Received
- October 30, 2009
- Decision date
- December 24, 2009
- 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 |
| 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 |
| K010521 | Nicolet VersalabJAF · Special | Nicolet Biomedical | 03/09/2001SE |
More from Nicolet Biomedical
| 510(k) | Device | Decision |
|---|---|---|
| K103693 | Vantage AbiDXN · Traditional | 02/15/2011SE |
| K101816 | STN ProbeITX · Special | 08/19/2010SE |
| K090499 | Lifedop Model, L350RMAA · Traditional | 03/31/2009SE |
| K063600 | Vista AvsJAF · Traditional | 12/19/2006SE |
| K060410 | Echoheart Transvaginal Doppler ProbeHEK · Traditional | 04/10/2006SE |
| K024197 | Lifedop DopplerKNG · Traditional | 01/03/2003SE |
Questions and answers
When was Lifedop Model 300ABI cleared by the FDA?
Lifedop Model 300ABI (K093393) received a 510(k) decision of Substantially Equivalent on December 24, 2009, 55 days after the submission was received.
What is the product code of K093393?
The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.