Esophageal Motility Apparatus
FDA 510(k) K812103 · Honeywell, Inc.
510(k) numberK812103
Submission
- Device name
- Esophageal Motility Apparatus
- Applicant
- Honeywell, Inc.
Walker, MI, US - Received
- July 24, 1981
- Decision date
- August 13, 1981
- 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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| K181760 | Transit-PelletsFFX · Traditional | Medifactia AB | 08/08/2019SE |
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| K851092 | Portable Defibrillator/Monitor Ed 425LDD · Traditional | 04/10/1985SE |
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Questions and answers
When was Esophageal Motility Apparatus cleared by the FDA?
Esophageal Motility Apparatus (K812103) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 20 days after the submission was received.
What is the product code of K812103?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.