FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
K Number: K120118
·
Decision May 24, 2012
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
22
Review Days
128
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Basic Information
- Device Name
- VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
- K Number
- K120118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ventlab Corp.
- Date Received
- January 17, 2012
- Decision Date
- May 24, 2012
- Product Code
- CAP
- 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | FDA class 2 | Anesthesiology |
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