FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
K Number: K961928
·
Decision Sep 16, 1996
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
11
Review Days
122
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Basic Information
- Device Name
- BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
- K Number
- K961928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedix, Inc.
- Date Received
- May 17, 1996
- Decision Date
- September 16, 1996
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Biomedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142097 | SELEC-3 I.V.ADMINISTRATION SET | Aug 29, 2014 | Substantially Equivalent |
| K122281 | PADNET 2.0 | Aug 29, 2012 | Substantially Equivalent |
| 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 |
| K973644 | FLOSTAT VASCULAR LAB | Dec 23, 1997 | Substantially Equivalent |
| K925645 | SELEC-3 | Sep 27, 1993 | Substantially Equivalent |
| K926498 | ENDOGRIP | Apr 7, 1993 | Substantially Equivalent |