FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
K Number: K050953
·
Decision Jun 29, 2005
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
4
Review Days
75
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
- K Number
- K050953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Air Safety, Ltd.
- Date Received
- April 15, 2005
- Decision Date
- June 29, 2005
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAH), ordered by most recent decision date.
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
FDA 510(k)
FDA Class 2
·Anesthesiology
Ambu® Virobac II® Exhalation Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
Besmed Bacterial Filter and HMEF
FDA 510(k)
FDA Class 2
·Anesthesiology
Breathing circuit bacterial/viral filter
FDA 510(k)
FDA Class 2
·Anesthesiology
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
FDA 510(k)
FDA Class 2
·Anesthesiology
TNI Clear-Guard 3 angled breathing filter (1545020)
FDA 510(k)
FDA Class 2
·Anesthesiology