FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO MEDICUS BIO CONSOLE 540
K Number: K854133
·
Decision Jan 8, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
36
Applicant Total
15
Review Days
90
Basic Information
- Device Name
- BIO MEDICUS BIO CONSOLE 540
- K Number
- K854133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- BIO MEDICUS, INC.
- Date Received
- October 10, 1985
- Decision Date
- January 8, 1986
- Product Code
- DWA
- 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by BIO MEDICUS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K920761 | URINE CULTUR STABILIZATION TRANSPORT TUBE | Jun 19, 1992 | Substantially Equivalent |
| K903410 | BIO-MEDICUS CANNULA INTRODUCER | Oct 31, 1990 | Substantially Equivalent |
| K901253 | (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 | Sep 5, 1990 | Substantially Equivalent |
| K901584 | BIO-MEDICUS BIO CONSOLE MODELS 540 A B C | Jun 28, 1990 | Substantially Equivalent |
| K894980 | BIO-CAL 370 HEATER/COOLER | Nov 2, 1989 | Substantially Equivalent |
| K884129 | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET | Dec 21, 1988 | Substantially Equivalent |
| K883956 | BIO-MEDICUS TUBING CONNECTORS | Oct 28, 1988 | Substantially Equivalent |
| K872033 | BIO-MEDICUS CANNULA-TUBING | Dec 7, 1987 | Substantially Equivalent |
| K861096 | CARDIOPULMONARY CANNULA TUBING | May 21, 1986 | Substantially Equivalent |
| K853126 | BIO PACK MODEL 200 | Oct 11, 1985 | Substantially Equivalent |