FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESSORY FOR ADULT VOL. VENTILATOR
K Number: K842580
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
20
Review Days
52
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
- ACCESSORY FOR ADULT VOL. VENTILATOR
- K Number
- K842580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Infrasonics Corp.
- Date Received
- July 3, 1984
- Decision Date
- August 24, 1984
- 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 Infrasonics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K943106 | ADULT VENTILATOR | Dec 28, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K952878 | OXY/STAR LOW FLOW BLENDER | Sep 25, 1995 | Substantially Equivalent |
| K934753 | STAR BREATHING CIRCUITS | Oct 27, 1993 | Substantially Equivalent |
| K922654 | VENTILATOR ADULT STAR MODIFICATION | Dec 1, 1992 | Substantially Equivalent |
| K923704 | INFANT STAR SERIES 500 | Oct 22, 1992 | Substantially Equivalent |
| K922477 | MODEL 105 VENTILATOR, MODIFICATION | Aug 24, 1992 | Substantially Equivalent |
| K920954 | AIR STAR | Aug 3, 1992 | Substantially Equivalent |
| K911804 | INFRASONICS VENTILATOR ADULT STAR, MODIFICATION | Jun 11, 1992 | Substantially Equivalent |
| K913972 | STAR SYNC, MODIFICATION | Jan 9, 1992 | Substantially Equivalent |
| K905272 | ADULT STAR, MODIFICATION | Jan 30, 1991 | Substantially Equivalent |