MOBILE LEAD PLASTIC X-RAY BARRIERS
FDA 510(k) clearance K850813 · decided 1985-04-10
Clearance details
- K-number
- K850813
- Device name
- MOBILE LEAD PLASTIC X-RAY BARRIERS
- Applicant
- Victoreen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-28
- Decision date
- 1985-04-10
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- IWX
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Carle Place, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| A2J MZ 45 LASER LIGHT FOR POSITIONING (K881591) | A2j, Inc. | 1988-04-27 |
| AUTOMATIC FILM PROCESSORIO M. R80 (K781068) | Tecnomed, Inc. | 1978-07-17 |
Recalls involving this device
No recalls on record reference this clearance.