FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTILATORY EFFORT MONITOR
K Number: K810153
·
Decision Feb 9, 1981
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
14
Review Days
19
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Basic Information
- Device Name
- VENTILATORY EFFORT MONITOR
- K Number
- K810153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2377
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medicon, Inc.
- Date Received
- January 21, 1981
- Decision Date
- February 9, 1981
- Product Code
- FLS
- 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 |
|---|---|---|---|
| FLS | Monitor, Apnea, Facility Use | FDA class 2 | Anesthesiology |
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