Pressure Monitor Manometric Sys.
FDA 510(k) K771265 · Physio-Control Corp.
510(k) numberK771265
Submission
- Device name
- Pressure Monitor Manometric Sys.
- Applicant
- Physio-Control Corp.
Mchenry, IL, US - Received
- July 13, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Pressure Monitor Manometric Sys. cleared by the FDA?
Pressure Monitor Manometric Sys. (K771265) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 132 days after the submission was received.
What is the product code of K771265?
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.