FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
DISPOSABLE PRESSURE MANOMETER
K Number: K140370
·
Decision Jun 19, 2014
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
10
Review Days
125
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Basic Information
- Device Name
- DISPOSABLE PRESSURE MANOMETER
- K Number
- K140370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Besmed Health Business Corp
- Date Received
- February 14, 2014
- Decision Date
- June 19, 2014
- 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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