Product code EAK
- Device name
- Screen, Leaded, Operator Radiation Protector
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.6500
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Victoreen, Inc. | 1995-06-16 |
| K944445 | ED CORP RADIATION SCREEN | Med Corp. | 1995-05-11 |
| K944772 | MULTIPLE ED1600 SERIES RADIATION SHIELDS | Image Diagnostics, Inc. | 1994-10-20 |
| K896949 | MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS | Innovative Products Mfg. | 1990-02-16 |
| K861019 | CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD | Phase One Disign Co. | 1986-04-02 |
| K850814 | MODULAR X-RAY BARRIERS | Victoreen, Inc. | 1985-04-10 |
| K850816 | LEAD PLASTIC VIEWING PANELS | Victoreen, Inc. | 1985-04-10 |
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