ELECTRODELCA
FDA 510(k) clearance K892659 · decided 1989-11-21
Clearance details
- K-number
- K892659
- Device name
- ELECTRODELCA
- Applicant
- Oldelft Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1989-04-13
- Decision date
- 1989-11-21
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- IZG
- Device class
- 2
- Regulation number
- 892.1730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Fairfax, VA, 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 |
|---|---|---|
| DISCOGRAPHY KIT (K960082) | Spinal Specialties, Inc. | 1996-03-21 |
| G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (K960146) | GE Medical Systems | 1996-02-27 |
| PXI PNEUMATIC COMPRESSION PADDLE (K913436) | Brotherston/Pxi | 1992-11-05 |
| MU125M MOBILE X-RAY SYSTEM (K920393) | Shimadzu Medical Systems | 1992-04-06 |
| DISCOGRAPHY KIT (K910503) | B. Braun of America, Inc. | 1991-10-07 |
| AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (K903808) | Advanced Med/Surg, Inc. | 1991-01-22 |
Recalls involving this device
No recalls on record reference this clearance.