FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)
K Number: K924208
·
Decision Jul 8, 1993
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
13
Review Days
322
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Basic Information
- Device Name
- BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)
- K Number
- K924208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Bio-Medicus, Inc.
- Date Received
- August 20, 1992
- Decision Date
- July 8, 1993
- Product Code
- DPT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by Medtronic Bio-Medicus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | Apr 27, 1998 | Substantially Equivalent |
| K973011 | BPX80 BIO-PUMP (BPX80) | Feb 25, 1998 | Substantially Equivalent |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Jan 16, 1996 | Substantially Equivalent |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | Feb 17, 1995 | Substantially Equivalent |
| K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER | Dec 23, 1994 | Substantially Equivalent |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | Jul 20, 1994 | Substantially Equivalent |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | Jun 2, 1993 | Substantially Equivalent |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | May 7, 1993 | Substantially Equivalent |
| K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 | May 6, 1993 | Substantially Equivalent |
| K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER | Mar 26, 1993 | Substantially Equivalent |