VTS1000
FDA 510(k) clearance K101838 · decided 2011-02-18
Clearance details
- K-number
- K101838
- Device name
- VTS1000
- Applicant
- Vuetek Scientific, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-07-01
- Decision date
- 2011-02-18
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- KZA
- Device class
- 1
- Regulation number
- 880.6970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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| HYPO-GRIP (K780884) | Harco Products | 1978-08-10 |
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Recalls involving this device
No recalls on record reference this clearance.