Disposable Blood Pressure Transducer Dom
FDA 510(k) K813053 · Bentley Laboratories, Inc.
510(k) numberK813053
Submission
- Device name
- Disposable Blood Pressure Transducer Dom
- Applicant
- Bentley Laboratories, Inc.
Mchenry, IL, US - Received
- October 29, 1981
- Decision date
- November 16, 1981
- 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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| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 11/09/2017SE |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 05/24/2017SE |
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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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Questions and answers
When was Disposable Blood Pressure Transducer Dom cleared by the FDA?
Disposable Blood Pressure Transducer Dom (K813053) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 18 days after the submission was received.
What is the product code of K813053?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.