Monaghan RVM, Model 760 and 761
FDA 510(k) K863612 · Monaghan Medical Corp.
510(k) numberK863612
Submission
- Device name
- Monaghan RVM, Model 760 and 761
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- September 16, 1986
- Decision date
- October 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was Monaghan RVM, Model 760 and 761 cleared by the FDA?
Monaghan RVM, Model 760 and 761 (K863612) received a 510(k) decision of Substantially Equivalent on October 15, 1986, 29 days after the submission was received.
What is the product code of K863612?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.