Esophageal Motility System - Model 3330
FDA 510(k) K780812 · Honeywell, Inc.
510(k) numberK780812
Submission
- Device name
- Esophageal Motility System - Model 3330
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- May 17, 1978
- Decision date
- June 13, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Esophageal Motility System - Model 3330 cleared by the FDA?
Esophageal Motility System - Model 3330 (K780812) received a 510(k) decision of Substantially Equivalent on June 13, 1978, 27 days after the submission was received.
What is the product code of K780812?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.