L-LINEX-RAY FLUORESCENCE
FDA 510(k) clearance K911749 · decided 1991-08-20
Clearance details
- K-number
- K911749
- Device name
- L-LINEX-RAY FLUORESCENCE
- Applicant
- Montifore Medical Center
- Decision
- Substantially Equivalent
- Date received
- 1991-04-18
- Decision date
- 1991-08-20
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- JAO
- Device class
- 2
- Regulation number
- 892.1220
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bronx, 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 |
|---|---|---|
| ABIOMED BODY LEAD ANALYZER MODEL 200/20 (K900574) | Abiomed, Inc. | 1990-03-15 |
Recalls involving this device
No recalls on record reference this clearance.