VIVATRAK
FDA 510(k) clearance K101109 · decided 2010-07-15
Clearance details
- K-number
- K101109
- Device name
- VIVATRAK
- Applicant
- Wireless Medcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-04-20
- Decision date
- 2010-07-15
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- KMI
- Device class
- 1
- Regulation number
- 880.2400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| LEAF PATIENT MONITORING SYSTEM (K141877) | Leaf Healthcare, Inc. | 2014-11-10 |
| INTEL-GE CARE INNOVATIONS QUIETCARE (K131585) | Intel-Ge Care Innovations, LLC | 2013-10-08 |
| DYNASENSE SYSTEM (K130752) | Centauri Medical, Inc. | 2013-08-15 |
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| ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (K942770) | Ultimate Development Corp. | 1994-12-23 |
| INFORMER PLUS (K943481) | Micro-Tech Medical, Inc. | 1994-11-02 |
| PM-PAGER (K933552) | Hill Engineering | 1994-09-22 |
| HOME AMB-ALERT (K934344) | Medway | 1994-04-29 |
| TELETOM (K940405) | Berchtold Holding GmbH | 1994-04-14 |
| SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 (K924433) | Senior Technologies, Inc. | 1993-06-24 |
| WANDER CARE (K925529) | Care Electronics, Inc. | 1993-06-16 |
| POSEY SITTER (K920206) | J. T. Posey Co. | 1992-05-14 |
Recalls involving this device
No recalls on record reference this clearance.