FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PM PUMP ASPIRATOR
K Number: K932494
·
Decision Oct 7, 1993
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
30
Review Days
136
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Basic Information
- Device Name
- PM PUMP ASPIRATOR
- K Number
- K932494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precision Medical, Inc.
- Date Received
- May 24, 1993
- Decision Date
- October 7, 1993
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
| K173807 | Accu O2 Oxygen Analyzer | May 2, 2018 | Substantially Equivalent |
| K140179 | EASY GO VAC | Apr 25, 2014 | Substantially Equivalent |
| K103563 | PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 | Jul 1, 2011 | Substantially Equivalent |
| K103324 | PRECISION LIQUID OXYGEN SYSTEM | Apr 21, 2011 | Substantially Equivalent |
| K090781 | HELIO2 BLENDER | Aug 13, 2009 | Substantially Equivalent |
| K072348 | PRECISION OXYGEN CONCENTRATOR | Oct 27, 2008 | Substantially Equivalent |
| K063096 | PRECISION OXYGEN MONITOR | Feb 27, 2007 | Substantially Equivalent |
| K053232 | PRECISION BLENDER | Jan 10, 2006 | Substantially Equivalent |
| K051691 | MINIMATE COMPRESSOR | Dec 9, 2005 | Substantially Equivalent |
| K041122 | PRECISION LIQUID OXYGEN SYSTEM | Oct 4, 2004 | Substantially Equivalent |