Ventilatory Effort Monitor
FDA 510(k) K810153 · Medicon, Inc.
510(k) numberK810153
Submission
- Device name
- Ventilatory Effort Monitor
- Applicant
- Medicon, Inc.
Mchenry, IL, US - Received
- January 21, 1981
- Decision date
- February 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLS – Monitor, Apnea, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2377
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Ventilatory Effort Monitor cleared by the FDA?
Ventilatory Effort Monitor (K810153) received a 510(k) decision of Substantially Equivalent on February 9, 1981, 19 days after the submission was received.
What is the product code of K810153?
The FDA product code is FLS – Monitor, Apnea, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.2377.