FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFRASONICS VENTILATOR ADULT STAR, MODIFICATION
K Number: K911804
·
Decision Jun 11, 1992
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
20
Review Days
414
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Basic Information
- Device Name
- INFRASONICS VENTILATOR ADULT STAR, MODIFICATION
- K Number
- K911804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Infrasonics Corp.
- Date Received
- April 24, 1991
- Decision Date
- June 11, 1992
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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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 |
| K913972 | STAR SYNC, MODIFICATION | Jan 9, 1992 | Substantially Equivalent |
| K905272 | ADULT STAR, MODIFICATION | Jan 30, 1991 | Substantially Equivalent |
| K896825 | TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR | Nov 16, 1990 | Substantially Equivalent |