Battery Operated Flow Rate Computer
FDA 510(k) K760756 · 3M Health Care, Sarns
510(k) numberK760756
Submission
- Device name
- Battery Operated Flow Rate Computer
- Applicant
- 3M Health Care, Sarns
Mchenry, IL, US - Received
- October 1, 1976
- Decision date
- October 15, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K960916 | Sams 8000 Cardioplegia MonitorDSJ · Traditional | 06/04/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 04/19/1996SE |
| K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemDWA · Traditional | 11/17/1995SE |
| K941653 | Sarns Turbo Membrane Oxygenator ModificationDTZ · Traditional | 08/24/1994SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 07/26/1994SE |
| K940651 | Sarns Ultrasonic Air SensorKRL · Traditional | 05/24/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 02/24/1994SE |
| K934127 | Sarns Low Jetting Aortic Arch CannulaDWF · Traditional | 02/22/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 02/04/1994SE |
| K915547 | Sarns 8000 Delphin II Centri Pump Mod W/Integr BatKFM · Traditional | 09/09/1993SE |
Questions and answers
When was Battery Operated Flow Rate Computer cleared by the FDA?
Battery Operated Flow Rate Computer (K760756) received a 510(k) decision of Substantially Equivalent on October 15, 1976, 14 days after the submission was received.
What is the product code of K760756?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.