FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOSTAT VASCULAR LAB
K Number: K973644
·
Decision Dec 23, 1997
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
37
Applicant Total
11
Review Days
90
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Basic Information
- Device Name
- FLOSTAT VASCULAR LAB
- K Number
- K973644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1540
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomedix, Inc.
- Date Received
- September 24, 1997
- Decision Date
- December 23, 1997
- 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 |
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Other Clearances by Biomedix, Inc.
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|---|---|---|---|
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| K073146 | PADNET+ | Nov 21, 2007 | Substantially Equivalent |
| K050182 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | Aug 9, 2005 | Substantially Equivalent |
| K042616 | BIOMEDIX PADNET LAB | Oct 12, 2004 | Substantially Equivalent |
| K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | May 21, 2004 | Substantially Equivalent |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Dec 29, 1997 | Substantially Equivalent |
| K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 | Sep 16, 1996 | Substantially Equivalent |
| K925645 | SELEC-3 | Sep 27, 1993 | Substantially Equivalent |
| K926498 | ENDOGRIP | Apr 7, 1993 | Substantially Equivalent |