Arterial Diagnostic Unit (Adu)
FDA 510(k) K770115 · Medical Electronic Devices, Inc.
510(k) numberK770115
Submission
- Device name
- Arterial Diagnostic Unit (Adu)
- Applicant
- Medical Electronic Devices, Inc.
Mchenry, IL, US - Received
- January 19, 1977
- Decision date
- February 1, 1977
- 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
Other 510(k)s with product code DPW
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|---|---|---|---|
| K260700 | BlueDop Vascular ExpertDPW · Traditional | BlueDop Medical, Ltd. | 07/08/2026SE |
| 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 |
|---|---|---|
| K052563 | Inogen Satellite Conserver, Model SC-100NFB · Traditional | 10/24/2005SE |
| K033197 | Inogen Satellite ConserverNFB · Traditional | 05/13/2004SE |
| K023420 | Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, ReactebNFB · Special | 10/25/2002SE |
| K983601 | Demand Oxygen Conserving Device, Docd, the DocNFB · Traditional | 12/15/1998SE |
| K983459 | Pulsed Oxygen Conserving Device, PocdNFB · Traditional | 12/08/1998SE |
| K761092 | Inguinal Compressive Device (Icd) · Traditional | 12/16/1976SE |
Questions and answers
When was Arterial Diagnostic Unit (Adu) cleared by the FDA?
Arterial Diagnostic Unit (Adu) (K770115) received a 510(k) decision of Substantially Equivalent on February 1, 1977, 13 days after the submission was received.
What is the product code of K770115?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.