GXP DENTAL X-RAY PROCESSOR
FDA 510(k) clearance K932675 · decided 1993-07-26
Clearance details
- K-number
- K932675
- Device name
- GXP DENTAL X-RAY PROCESSOR
- Applicant
- Gendex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-02
- Decision date
- 1993-07-26
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- EGN
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gendex Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (K851720) | Artiberia | 1985-07-02 |
| TONSIL SCISSORS 7 (K821292) | Conphar, Inc. | 1982-05-28 |
| MAYO SCISSOR CURYED 5 1/2 (K821276) | Conphar, Inc. | 1982-05-28 |
| TONSIL SCISSORS STRAIGHT 5 1/2 (K821294) | Conphar, Inc. | 1982-05-28 |
| MAYO SCISSOR STRAIGHT 5 1/2 (K821275) | Conphar, Inc. | 1982-05-28 |
| CONPHAR (K821077) | Conphar, Inc. | 1982-05-24 |
Recalls involving this device
No recalls on record reference this clearance.