ROENTGENOGRAPHY SET
FDA 510(k) clearance K830229 · decided 1983-03-09
Clearance details
- K-number
- K830229
- Device name
- ROENTGENOGRAPHY SET
- Applicant
- Mallinckrodt Critical Care
- Decision
- Substantially Equivalent
- Date received
- 1983-01-24
- Decision date
- 1983-03-09
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- DGD
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Walker, MI, 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 |
|---|---|---|
| FERRITIN CONTROL - LEVEL 1, 2, 3 (K946266) | Clinical Controls, Inc. | 1995-02-10 |
| IMX FERRITIN (K881345) | Abbott Laboratories | 1988-05-11 |
Recalls involving this device
No recalls on record reference this clearance.