Imagyn Medical Inflation Device with Non-Invasive Pressure Tubing
FDA 510(k) K940425 · Imagyn Medical, Inc.
510(k) numberK940425
Submission
- Device name
- Imagyn Medical Inflation Device with Non-Invasive Pressure Tubing
- Applicant
- Imagyn Medical, Inc.
Laguna Niguel, CA, US - Received
- January 31, 1994
- Decision date
- August 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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| K952032 | Imagyn Hysteroscope SheathsHIH · Traditional | 10/31/1995SE |
| K951996 | Imagyn EndoscopeGCJ · Traditional | 09/01/1995SE |
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Questions and answers
When was Imagyn Medical Inflation Device with Non-Invasive Pressure Tubing cleared by the FDA?
Imagyn Medical Inflation Device with Non-Invasive Pressure Tubing (K940425) received a 510(k) decision of Substantially Equivalent on August 1, 1994, 182 days after the submission was received.
What is the product code of K940425?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.