Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure Catheter, Model GIA-8500
FDA 510(k) K022023 · Clinical Innovations, Inc.
510(k) numberK022023
Submission
- Device name
- Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure Catheter, Model GIA-8500
- Applicant
- Clinical Innovations, Inc.
Murray, UT, US - Received
- June 20, 2002
- Decision date
- January 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure Catheter, Model GIA-8500 cleared by the FDA?
Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure Catheter, Model GIA-8500 (K022023) received a 510(k) decision of Substantially Equivalent on January 7, 2003, 201 days after the submission was received.
What is the product code of K022023?
The FDA product code is KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube, a Class II (moderate risk) device regulated under 21 CFR 876.1725.