FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONAGHAN RVM, MODEL 761
K Number: K884942
·
Decision Jun 7, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
33
Review Days
194
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Basic Information
- Device Name
- MONAGHAN RVM, MODEL 761
- K Number
- K884942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Monaghan Medical Corp.
- Date Received
- November 25, 1988
- Decision Date
- June 7, 1989
- Product Code
- BZK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | FDA class 2 | Anesthesiology |
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