Bio-Probe(R) Blood Flow Monitoring SYST(TX-50/50P)
FDA 510(k) K924208 · Medtronic Bio-Medicus, Inc.
510(k) numberK924208
Submission
- Device name
- Bio-Probe(R) Blood Flow Monitoring SYST(TX-50/50P)
- Applicant
- Medtronic Bio-Medicus, Inc.
Eden Prairie, MN, US - Received
- August 20, 1992
- Decision date
- July 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2120
- Specialty
- Cardiovascular
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| K924206 | Medtronic Bio-Medicus Bio-Console Model 540EDWA · Traditional | 05/07/1993SE |
| K924205 | Medtronic Bio-Medicus Bio-Console Model 550DWA · Traditional | 05/06/1993SE |
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Questions and answers
When was Bio-Probe(R) Blood Flow Monitoring SYST(TX-50/50P) cleared by the FDA?
Bio-Probe(R) Blood Flow Monitoring SYST(TX-50/50P) (K924208) received a 510(k) decision of Substantially Equivalent on July 8, 1993, 322 days after the submission was received.
What is the product code of K924208?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.