FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
K Number: K050309
·
Decision Mar 25, 2005
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
7
Review Days
45
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Basic Information
- Device Name
- PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
- K Number
- K050309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Viasys Medsystems
- Date Received
- February 8, 2005
- Decision Date
- March 25, 2005
- 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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| K063061 | CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | Apr 2, 2007 | Substantially Equivalent |
| K043044 | ANTI-I.V. ENTERAL FEEDING SYSTEM | May 6, 2005 | Substantially Equivalent |
| K043004 | STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 | Mar 16, 2005 | Substantially Equivalent |
| K041987 | CORTRAK | Dec 17, 2004 | Substantially Equivalent |