FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-RAY COLLIMATING DEVICES
K Number: K810598
·
Decision Apr 10, 1981
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
31
Review Days
35
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Basic Information
- Device Name
- X-RAY COLLIMATING DEVICES
- K Number
- K810598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Midmark Corp.
- Date Received
- March 6, 1981
- Decision Date
- April 10, 1981
- Product Code
- IZW
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZW | Collimator, Automatic, Radiographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZW), ordered by most recent decision date.
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MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
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MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
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|---|---|---|---|
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| 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 |