FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
K Number: K090670
·
Decision Jul 7, 2009
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
31
Review Days
116
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Basic Information
- Device Name
- MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
- K Number
- K090670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Midmark Corp.
- Date Received
- March 13, 2009
- Decision Date
- July 7, 2009
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Midmark Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C | Jan 7, 2013 | Substantially Equivalent |
| K112380 | CLEARVISION | Nov 22, 2011 | Substantially Equivalent |
| K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER | Mar 3, 2003 | Substantially Equivalent |
| K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | Oct 18, 2000 | Substantially Equivalent |
| K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER | Jan 10, 2000 | Substantially Equivalent |
| K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Apr 19, 1999 | Substantially Equivalent |
| K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Nov 30, 1994 | Substantially Equivalent |
| K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | Oct 21, 1994 | Substantially Equivalent |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | Mar 28, 1994 | Substantially Equivalent |
| K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER | Feb 9, 1994 | Substantially Equivalent |