FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K Number: K936181
·
Decision Nov 30, 1994
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
31
Review Days
338
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Basic Information
- Device Name
- MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
- K Number
- K936181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Midmark Corp.
- Date Received
- December 27, 1993
- Decision Date
- November 30, 1994
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER | Mar 3, 2003 | Substantially Equivalent |
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| 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 |
| 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 |