IWS — Shield, Eye, Radiological Class I
FDA product code IWS covers "Shield, Eye, Radiological", a Class I medical device regulated under 21 CFR 892.6500. Submissions are reviewed by the Radiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IWS
- Device Class
- Class I
- Regulation Number
- 892.6500
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K945515 | Medtec | COATED TUNGSTEN EYESHIELD | Jun 19, 1995 |
| K940119 | Best Industries | ROYAL MARSDEN GOLD GRAIN GUN | Dec 30, 1994 |
| K943011 | Medtec | TUNGSTEN EYESHIELD | Dec 23, 1994 |
| K934459 | Med-Genesis | MED-GENESIS PATIENT LASER EYE SHIELD | Feb 22, 1994 |
| K934362 | Victoreen | NUCLEAR ASSOCIATES GLASSERS | Nov 12, 1993 |
| K920540 | Burkhart Roentgen Intl | RADIOLOGICAL PROTECTIVE EYE SHIELD | May 28, 1992 |