Sonicaid Model Vasoflo 4
FDA 510(k) K895909 · Oxford Medilog, Inc.
510(k) numberK895909
Submission
- Device name
- Sonicaid Model Vasoflo 4
- Applicant
- Oxford Medilog, Inc.
Clearwater, FL, US - Received
- October 10, 1989
- Decision date
- July 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K090499 | Lifedop Model, L350RMAA · Traditional | Summit Doppler Systems, Inc. | 03/31/2009SE |
| 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 |
| K894992 | Quantum Qad Angiodynograph Ultrasound SystemMAA · Traditional | Quantum Medical Systems, Inc. | 02/23/1990SE |
More from Quantum Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923737 | Model Medilog RapideBZQ · Traditional | 01/05/1994SE |
| K920295 | Medilog Excel ECG Analysis System (Modified)DQK · Traditional | 08/18/1992SE |
| K912890 | Model Sonicaid AxisHGM · Traditional | 01/09/1992SE |
| K912639 | Sonicaid TeamHGM · Traditional | 12/31/1991SE |
| K904763 | Mentor EEG SystemGWQ · Traditional | 04/10/1991SE |
| K902690 | Sonicaid Model Meridian 800HGM · Traditional | 02/05/1991SE |
| K896535 | Medilog OptimaDSK · Traditional | 01/18/1990SE |
| K891383 | Medilog 9200 EEG Replay/Analysis SystemOLZ · Traditional | 06/01/1989SE |
| K890330 | Medilog 6000-FD Report GeneratorDSI · Traditional | 04/20/1989SE |
| K890338 | Medilog EditorDSI · Traditional | 04/19/1989SE |
Questions and answers
When was Sonicaid Model Vasoflo 4 cleared by the FDA?
Sonicaid Model Vasoflo 4 (K895909) received a 510(k) decision of Substantially Equivalent on July 9, 1990, 272 days after the submission was received.
What is the product code of K895909?
The FDA product code is MAA – Monitor, Fetal Doppler Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 884.2660.