FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIR STAR
K Number: K920954
·
Decision Aug 3, 1992
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
20
Review Days
159
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 STAR
- K Number
- K920954
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Infrasonics Corp.
- Date Received
- February 26, 1992
- Decision Date
- August 3, 1992
- Product Code
- BTI
- 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 |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTI), ordered by most recent decision date.
OMBRA TABLE TOP COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDICAL AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DK50 DS
FDA 510(k)
FDA Class 2
·Anesthesiology
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDICAL COMPRESSOR, MODELS DK50 D AND DM
FDA 510(k)
FDA Class 2
·Anesthesiology
MINIMATE COMPRESSOR
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 |
| 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 |
| K896825 | TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR | Nov 16, 1990 | Substantially Equivalent |