Doppler Needle and Flow Monitor
FDA 510(k) K903625 · Peripheral Systems Group
510(k) numberK903625
Submission
- Device name
- Doppler Needle and Flow Monitor
- Applicant
- Peripheral Systems Group
Mountain View, CA, US - Received
- August 10, 1990
- Decision date
- November 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K932777 | Smartneedle(R) Over-The-Needle CatheterITX · Traditional | 10/07/1993SE |
| K931327 | PSG Directional Hydrophilic Guide WireDQX · Traditional | 07/14/1993SE |
| K915554 | Hi-Torque Sport-T(Tm) Guide WireDQX · Traditional | 02/09/1993SE |
| K914979 | Edm(R) Infusion CatheterKRA · Traditional | 09/16/1992SE |
| K913941 | Psg(Tm) 20 Guage Doppler NeedleITX · Traditional | 02/27/1992SE |
| K915168 | Proflex 5LIT · Traditional | 02/19/1992SE |
| K913477 | Apex(Tm) Prostatic Balloon Dilation CatheterKOE · Traditional | 12/27/1991SE |
| K913746 | Smartneedle(Tm) Vascular Access SystemITX · Traditional | 12/17/1991SE |
Questions and answers
When was Doppler Needle and Flow Monitor cleared by the FDA?
Doppler Needle and Flow Monitor (K903625) received a 510(k) decision of Substantially Equivalent on November 7, 1990, 89 days after the submission was received.
What is the product code of K903625?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.