FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDMARK SURGICAL LIGHTING SYSTEMS
K Number: K930686
·
Decision Jul 30, 1993
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
6
Applicant Total
31
Review Days
170
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Basic Information
- Device Name
- MIDMARK SURGICAL LIGHTING SYSTEMS
- K Number
- K930686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Midmark Corp.
- Date Received
- February 10, 1993
- Decision Date
- July 30, 1993
- Product Code
- FSQ
- 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 |
|---|---|---|---|
| FSQ | Light, Surgical, Instrument | FDA class 2 | General, Plastic Surgery |
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SURG-FLEX 5 SURGICAL LIGHT
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SURG-FLEX 15 SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K090670 | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER | Jul 7, 2009 | 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 |