Lifedop Model, L350R
FDA 510(k) K090499 · Summit Doppler Systems, Inc.
510(k) numberK090499
Submission
- Device name
- Lifedop Model, L350R
- Applicant
- Summit Doppler Systems, Inc.
Golden, CO, US - Received
- February 25, 2009
- Decision date
- March 31, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- MAA – Monitor, Fetal Doppler Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MAA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerMAA · Traditional | Edan Instruments, Inc. | 10/28/2010SE |
| K915138 | GE SonochromeMAA · Traditional | GE Medical Systems | 10/20/1992SE |
| K905536 | Fetal DopplerMAA · Traditional | Toshiba America Medical Systems, In.C | 04/21/1992SE |
| K904600 | L582 TransducerMAA · Traditional | Acuson Corp. | 06/24/1991SE |
| K905456 | L328 TransducerMAA · Traditional | Acuson Corp. | 05/28/1991SE |
| K904951 | S5192R TransducerMAA · Traditional | Acuson Corp. | 04/29/1991SE |
| K895909 | Sonicaid Model Vasoflo 4MAA · Traditional | Oxford Medilog, Inc. | 07/09/1990SE |
| K894992 | Quantum Qad Angiodynograph Ultrasound SystemMAA · Traditional | Quantum Medical Systems, Inc. | 02/23/1990SE |
More from Quantum Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K103693 | Vantage AbiDXN · Traditional | 02/15/2011SE |
| K101816 | STN ProbeITX · Special | 08/19/2010SE |
| K093393 | Lifedop Model 300ABIJAF · Traditional | 12/24/2009SE |
| 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, L350R cleared by the FDA?
Lifedop Model, L350R (K090499) received a 510(k) decision of Substantially Equivalent on March 31, 2009, 34 days after the submission was received.
What is the product code of K090499?
The FDA product code is MAA – Monitor, Fetal Doppler Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 884.2660.