Disposable Flush Device
FDA 510(k) K860681 · Hewlett-Packard Co.
510(k) numberK860681
Submission
- Device name
- Disposable Flush Device
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- February 25, 1986
- Decision date
- June 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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| K152980 | Flo Trac sensor, Volume View sensorDRS · Traditional | Edwards Lifesciences, LLC | 01/19/2016SE |
| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure…DRS · Traditional | Biometrix , Ltd. | 09/04/2015SE |
| K133624 | Compass CT, Compass CT PortDRS · Traditional | Mirador Biomedical | 04/18/2014SE |
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| K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…MHX · Abbreviated | 01/28/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | 01/20/2000SE |
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| K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-St Segment Measurement…MHX · Special | 12/08/1999SE |
| K992977 | Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AMKJ · Traditional | 12/01/1999SE |
| K993516 | HP M2600A Viridia Telemetry SystemDSI · Special | 11/08/1999SE |
| K992674 | HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027AMHX · Abbreviated | 11/08/1999SE |
| K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special | 10/21/1999SE |
Questions and answers
When was Disposable Flush Device cleared by the FDA?
Disposable Flush Device (K860681) received a 510(k) decision of Substantially Equivalent on June 17, 1986, 112 days after the submission was received.
What is the product code of K860681?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.