FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PM3000 & PM3100 VACUUM REGULATOR
K Number: K922817
·
Decision Mar 4, 1993
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
20
Applicant Total
30
Review Days
266
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Basic Information
- Device Name
- PM3000 & PM3100 VACUUM REGULATOR
- K Number
- K922817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precision Medical, Inc.
- Date Received
- June 11, 1992
- Decision Date
- March 4, 1993
- Product Code
- KDP
- 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 |
|---|---|---|---|
| KDP | Regulator, Vacuum | FDA class 2 | General Hospital |
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| K063096 | PRECISION OXYGEN MONITOR | Feb 27, 2007 | Substantially Equivalent |
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| K051691 | MINIMATE COMPRESSOR | Dec 9, 2005 | Substantially Equivalent |
| K041122 | PRECISION LIQUID OXYGEN SYSTEM | Oct 4, 2004 | Substantially Equivalent |