Ultrasonic QFM System 1000
FDA 510(k) K811376 · Narco Bio-Systems
510(k) numberK811376
Submission
- Device name
- Ultrasonic QFM System 1000
- Applicant
- Narco Bio-Systems
Mchenry, IL, US - Received
- May 15, 1981
- Decision date
- August 13, 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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| K252810 | FloPatch FP120DPW · Special | Flosonics Medical | 04/24/2026SE |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | Remington Medical, Inc. | 11/20/2025SE |
| K251114 | FloPatch FP120DPW · Traditional | Flosonics Medical | 06/20/2025SE |
| K243852 | Elfor-LDPW · Traditional | Elfi-Tech , Ltd. | 04/14/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | Remington Medical, Inc. | 08/30/2024SE |
| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 01/27/2022SE |
More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853683 | UMS-100FAP · Traditional | 01/10/1986SE |
| K833656 | Narcotrace 40 - NT40DSF · Traditional | 05/09/1984SE |
| K832869 | Motility Measurement Sys MMS-100FFX · Traditional | 10/31/1983SE |
| K813502 | Narco Telecare Isoflo Pressure MonitorDRS · Traditional | 12/29/1981SE |
| K810431 | Narco Tlecare Miniature Pressure DomeDRS · Traditional | 03/11/1981SE |
| K801544 | Porta-Fib LPDLDD · Traditional | 07/14/1980SE |
| K760084 | Monitor, GSR (NB-401)HCC · Traditional | 07/26/1976SE |
| K760083 | Physioscope · Traditional | 07/20/1976SE |
Questions and answers
When was Ultrasonic QFM System 1000 cleared by the FDA?
Ultrasonic QFM System 1000 (K811376) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 90 days after the submission was received.
What is the product code of K811376?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.