Device |
gastrointestinal motility system, capsule |
Regulation Description |
Gastrointestinal motility monitoring system. |
Definition |
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders. |
Physical State |
Small ingestible capsule transmits motility data to a wireless receiver worn by the subject. Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software. |
Technical Method |
Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient. |
Target Area |
Device is swallowed, and passes through the GI tract |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | NYV |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.1725
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |