FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VBMAX
K Number: K000654
·
Decision Nov 14, 2000
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
2
Review Days
260
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
- VBMAX
- K Number
- K000654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A-M Systems, Inc.
- Date Received
- February 28, 2000
- Decision Date
- November 14, 2000
- 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
Other Clearances by A-M Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063526 | A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER | Jun 29, 2007 | Substantially Equivalent |