STASIS BUTTON PRSSURE DEVICE
FDA 510(k) clearance K912765 · decided 1991-08-12
Clearance details
- K-number
- K912765
- Device name
- STASIS BUTTON PRSSURE DEVICE
- Applicant
- Arch Development Group
- Decision
- Substantially Equivalent
- Date received
- 1991-06-24
- Decision date
- 1991-08-12
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- MHW
- Device class
- 1
- Regulation number
- 880.5075
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Louis, MO, 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 |
|---|---|---|
| SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB (K070457) | Sun Scientific, LLC | 2007-05-16 |
Recalls involving this device
No recalls on record reference this clearance.