FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-CAL 370 HEATER/COOLER
K Number: K894980
·
Decision Nov 2, 1989
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
15
Review Days
86
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Basic Information
- Device Name
- BIO-CAL 370 HEATER/COOLER
- K Number
- K894980
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bio Medicus, Inc.
- Date Received
- August 8, 1989
- Decision Date
- November 2, 1989
- Product Code
- DWJ
- 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |
| K854133 | BIO MEDICUS BIO CONSOLE 540 | Jan 8, 1986 | Substantially Equivalent |
| K853126 | BIO PACK MODEL 200 | Oct 11, 1985 | Substantially Equivalent |