SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
FDA 510(k) clearance K092713 · decided 2010-07-16
Clearance details
- K-number
- K092713
- Device name
- SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
- Applicant
- Transamerican Medical Imaging
- Decision
- Substantially Equivalent
- Date received
- 2009-09-03
- Decision date
- 2010-07-16
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lindon, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spect recall (Z-0532-2014) | Trans American Medical, Inc. | 2014-01-03 |