Narco Telecare Isoflo Pressure Monitor
FDA 510(k) K813502 · Narco Bio-Systems
510(k) numberK813502
Submission
- Device name
- Narco Telecare Isoflo Pressure Monitor
- Applicant
- Narco Bio-Systems
Mchenry, IL, US - Received
- December 15, 1981
- Decision date
- December 29, 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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| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 05/24/2017SE |
| K161408 | Compass Cast and MAPDRS · Traditional | Centurion Medical Products Corporation | 11/22/2016SE |
| K152472 | Disposable Pressure TransducerDRS · Traditional | Zhejiang Haisheng Medical Device Co., Ltd. | 10/31/2016SE |
| 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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More from Mirador Biomedical
| 510(k) | Device | Decision |
|---|---|---|
| K853683 | UMS-100FAP · Traditional | 01/10/1986SE |
| K833656 | Narcotrace 40 - NT40DSF · Traditional | 05/09/1984SE |
| K832869 | Motility Measurement Sys MMS-100FFX · Traditional | 10/31/1983SE |
| K811376 | Ultrasonic QFM System 1000DPW · Traditional | 08/13/1981SE |
| K810431 | Narco Tlecare Miniature Pressure DomeDRS · Traditional | 03/11/1981SE |
| K801544 | Porta-Fib LPDLDD · Traditional | 07/14/1980SE |
| K760084 | Monitor, GSR (NB-401)HCC · Traditional | 07/26/1976SE |
| K760083 | Physioscope · Traditional | 07/20/1976SE |
Questions and answers
When was Narco Telecare Isoflo Pressure Monitor cleared by the FDA?
Narco Telecare Isoflo Pressure Monitor (K813502) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 14 days after the submission was received.
What is the product code of K813502?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.