FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPACT 901 SERIES PORT-A-WALL
K Number: K850671
·
Decision Mar 11, 1985
Classifications
1
FEI Numbers
278
Registration Numbers
278
Same Product Code
35
Applicant Total
27
Review Days
19
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Basic Information
- Device Name
- IMPACT 901 SERIES PORT-A-WALL
- K Number
- K850671
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6990
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Impact Instrumentation, Inc.
- Date Received
- February 20, 1985
- Decision Date
- March 11, 1985
- Product Code
- FOX
- 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 |
|---|---|---|---|
| FOX | Stand, Infusion | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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IV POLE/STAND
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IV SHUTTLE
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Other Clearances by Impact Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133196 | IMPACT MODEL 323 ASPIRATOR | Mar 10, 2014 | Substantially Equivalent |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR | Feb 16, 2012 | Substantially Equivalent |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR | Apr 7, 2011 | Substantially Equivalent |
| K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ | Aug 13, 2009 | Substantially Equivalent |
| K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV | Dec 10, 2008 | Substantially Equivalent |
| K051476 | UNI-VENT MODEL 73X | Oct 28, 2005 | Substantially Equivalent |
| K032386 | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) | Mar 26, 2004 | Substantially Equivalent |
| K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 | May 6, 2003 | Substantially Equivalent |
| K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT | Apr 18, 1995 | Substantially Equivalent |
| K941096 | ELECTRIC VACUM PUMP | Jan 5, 1995 | Substantially Equivalent |