FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
K Number: K981747
·
Decision Aug 20, 1998
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
7
Review Days
94
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Basic Information
- Device Name
- BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
- K Number
- K981747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunscope Intl., Inc.
- Date Received
- May 18, 1998
- Decision Date
- August 20, 1998
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by Sunscope Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | Nov 17, 2000 | Substantially Equivalent |
| K983372 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | Feb 5, 1999 | Substantially Equivalent |
| K973477 | BIOSENSORS EMBOLECTOMY CATHETER | Sep 4, 1998 | Substantially Equivalent |
| K981745 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | Jul 17, 1998 | Substantially Equivalent |
| K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | Oct 23, 1991 | Substantially Equivalent |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | Sep 27, 1991 | Substantially Equivalent |