Doppler Ultrasound Blood Flowmeter
FDA 510(k) K811246 · Irex Corp.
510(k) numberK811246
Submission
- Device name
- Doppler Ultrasound Blood Flowmeter
- Applicant
- Irex Corp.
Mchenry, IL, US - Received
- May 5, 1981
- Decision date
- August 12, 1981
- 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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| K840139 | Irex 720 Sector ScannerIYO · Traditional | 05/09/1984SE |
| K827370 | Irex System II 2D/DOPPLER Imaging System · Traditional | 06/28/1982SE |
| K813544 | Irex 2D/DOPPLER Phase Array Imaging Sys.IYN · Traditional | 02/05/1982SE |
| K792525 | Irex CardioplanDQK · Traditional | 12/27/1979SE |
| K791317 | Irex Real Time Phased Array SystemCDP · Traditional | 09/17/1979SE |
| K771372 | System IIDSF · Traditional | 08/04/1977SE |
Questions and answers
When was Doppler Ultrasound Blood Flowmeter cleared by the FDA?
Doppler Ultrasound Blood Flowmeter (K811246) received a 510(k) decision of Substantially Equivalent on August 12, 1981, 99 days after the submission was received.
What is the product code of K811246?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.