PASTURE, MODELS: F550, A520
FDA 510(k) clearance K083176 · decided 2009-01-23
Clearance details
- K-number
- K083176
- Device name
- PASTURE, MODELS: F550, A520
- Applicant
- Pasture Pharma Pte, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-28
- Decision date
- 2009-01-23
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- NZJ
- Device class
- 2
- Regulation number
- 880.6260
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Murrieta, CA, 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 |
|---|---|---|
| 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR (DEN060009) | 3M Company | 2007-05-08 |
Recalls involving this device
No recalls on record reference this clearance.