Monaghan RVM, Model 760 or Model 761
FDA 510(k) K853047 · Monaghan Medical Corp.
510(k) numberK853047
Submission
- Device name
- Monaghan RVM, Model 760 or Model 761
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- July 19, 1985
- Decision date
- November 18, 1985
- 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 or Model 761 cleared by the FDA?
Monaghan RVM, Model 760 or Model 761 (K853047) received a 510(k) decision of Substantially Equivalent on November 18, 1985, 122 days after the submission was received.
What is the product code of K853047?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.