FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
FAST1 INTRAOSSEOUS INFUSION SYSTEM
K Number: K072487
·
Decision Feb 13, 2008
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
162
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Basic Information
- Device Name
- FAST1 INTRAOSSEOUS INFUSION SYSTEM
- K Number
- K072487
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pyng Medical Corp.
- Date Received
- September 4, 2007
- Decision Date
- February 13, 2008
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Pyng Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130487 | FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE | Jun 25, 2013 | Substantially Equivalent |
| K100124 | FASTX STERNAL INTRAOSSEOUS DEVICE | Aug 31, 2010 | Substantially Equivalent |
| K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | Apr 24, 2008 | Substantially Equivalent |
| K970380 | F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM | Apr 25, 1997 | Substantially Equivalent |