Puma Model Version 1.0
510(k) K100801
Puma Model Version 1.0 is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K100801 on 18 Jun 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100801 | Date18 Jun 2010 | StatusActive |
Official records
- FDA 510(k) database K100801
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K100801
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Panther OIS|R&V v2.31 | v2.31 | 00859032007095 | — | No longer on the market |
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