FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUNGSTEN EYESHIELD
K Number: K943011
·
Decision Dec 23, 1994
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
5
Applicant Total
41
Review Days
182
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Basic Information
- Device Name
- TUNGSTEN EYESHIELD
- K Number
- K943011
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtec, Inc.
- Date Received
- June 24, 1994
- Decision Date
- December 23, 1994
- Product Code
- IWS
- 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 |
|---|---|---|---|
| IWS | Shield, Eye, Radiological | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWS), ordered by most recent decision date.
COATED TUNGSTEN EYESHIELD
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ROYAL MARSDEN GOLD GRAIN GUN
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MED-GENESIS PATIENT LASER EYE SHIELD
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NUCLEAR ASSOCIATES GLASSERS
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RADIOLOGICAL PROTECTIVE EYE SHIELD
FDA 510(k)
FDA Class 1
·Radiology
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| K973842 | CARBON FIBER CONFORMAL COUCH TOP | Dec 5, 1997 | Substantially Equivalent |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Oct 1, 1996 | Substantially Equivalent |
| K955236 | GREEN TEC-2100 | May 24, 1996 | Substantially Equivalent |
| K954705 | ACRYSTEEL BLOCKING TRAY | Jan 5, 1996 | Substantially Equivalent |
| K954456 | THERMOPLASTIC SHIELD | Dec 21, 1995 | Substantially Equivalent |