DECOMAT A 8666
FDA 510(k) clearance K920413 · decided 1994-04-05
Clearance details
- K-number
- K920413
- Device name
- DECOMAT A 8666
- Applicant
- Getinge International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-31
- Decision date
- 1994-04-05
- Days to decision
- 795 days
- Clearance type
- Traditional
- Product code
- MDZ
- Device class
- 2
- Regulation number
- 880.6992
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lakewood, NJ, 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 |
|---|---|---|
| DECOMAT 228 (K920406) | Getinge International, Inc. | 1994-04-05 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Di recall (Z-0908-03) | Getinge/Castle, Inc. | 2003-06-05 |