THD
FDA 510(k) K070815 · G.F. S.R.L.
510(k) numberK070815
Submission
- Device name
- THD
- Applicant
- G.F. S.R.L.
North Reading, MA, US - Received
- March 26, 2007
- Decision date
- June 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
Questions and answers
When was THD cleared by the FDA?
THD (K070815) received a 510(k) decision of Substantially Equivalent on June 20, 2007, 86 days after the submission was received.
What is the product code of K070815?
The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.