Giphy Monitor
FDA 510(k) K883960 · Vascular Technology Incorporated
510(k) numberK883960
Submission
- Device name
- Giphy Monitor
- Applicant
- Vascular Technology Incorporated
Chelmsford, MA, US - Received
- September 20, 1988
- Decision date
- October 4, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFT – Electrode, Ph, Stomach
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1400
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Giphy Monitor cleared by the FDA?
Giphy Monitor (K883960) received a 510(k) decision of Substantially Equivalent on October 4, 1989, 379 days after the submission was received.
What is the product code of K883960?
The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.