FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSENSOR BIDOP VASCULAR TEST SYSTEM
K Number: K943338
·
Decision Apr 12, 1996
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
37
Applicant Total
10
Review Days
640
Basic Information
- Device Name
- BIOSENSOR BIDOP VASCULAR TEST SYSTEM
- K Number
- K943338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1540
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIOSENSOR CORP.
- Date Received
- July 12, 1994
- Decision Date
- April 12, 1996
- Product Code
- JAF
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAF), ordered by most recent decision date.
Laminar P1 (LDH-HW-001)
FDA 510(k)
FDA Class 2
·Radiology
THD REVOLUTION
FDA 510(k)
FDA Class 2
·Radiology
SIMPLEABI
FDA 510(k)
FDA Class 2
·Radiology
LIFEDOP MODEL 300ABI
FDA 510(k)
FDA Class 2
·Radiology
THD SLIDE ONE
FDA 510(k)
FDA Class 2
·Radiology
THD SLIDE
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by BIOSENSOR CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K990956 | BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 | Jun 14, 1999 | Substantially Equivalent |
| K974546 | BIOSENSOR HOLTER MONITOR SYSTEM | Mar 4, 1998 | Substantially Equivalent |
| K974192 | BIOSENSOR HOLTER MONITOR SYSTEM | Mar 4, 1998 | Substantially Equivalent |
| K950944 | AMBULATORY (HOLTER) RECORDING SYSTEM | Jun 18, 1996 | Substantially Equivalent |
| K960449 | PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) | May 30, 1996 | Substantially Equivalent |
| K950723 | AMBULATORY (HOLTER) RECORDING SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K922027 | AMBULATORY (HOLTER) RECORDING, MODIFICATION | Feb 17, 1993 | Substantially Equivalent |
| K895266 | AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED | Jan 26, 1990 | Substantially Equivalent |
| K831676 | BIOSENSOR ASC SYSTEM | Dec 1, 1983 | Substantially Equivalent |