Trantecsilicone Quartz Disp. Transd
FDA 510(k) K833792 · American Bentley
510(k) numberK833792
Submission
- Device name
- Trantecsilicone Quartz Disp. Transd
- Applicant
- American Bentley
Mchenry, IL, US - Received
- October 31, 1983
- Decision date
- February 10, 1984
- 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 |
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| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
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Questions and answers
When was Trantecsilicone Quartz Disp. Transd cleared by the FDA?
Trantecsilicone Quartz Disp. Transd (K833792) received a 510(k) decision of Substantially Equivalent on February 10, 1984, 102 days after the submission was received.
What is the product code of K833792?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.