OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
FDA 510(k) clearance K081094 · decided 2008-06-20
Clearance details
- K-number
- K081094
- Device name
- OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
- Applicant
- Olympic Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-17
- Decision date
- 2008-06-20
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- MEC
- Device class
- 2
- Regulation number
- 880.6992
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
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| DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 (K911120) | Hamo USA, Inc. | 1994-02-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and recall (Z-2701-2017) | Natus Medical Incorporated | 2017-06-02 |