FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAR BREATHING CIRCUITS
K Number: K934753
·
Decision Oct 27, 1993
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
20
Review Days
23
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Basic Information
- Device Name
- STAR BREATHING CIRCUITS
- K Number
- K934753
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Infrasonics Corp.
- Date Received
- October 4, 1993
- Decision Date
- October 27, 1993
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
UNICOR, INC. CORRUGATED TUBING
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UNICOR, INC. VENTILATOR HOSES
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PRIMA VENTILATOR HOSES
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PRIMA CUSTOM ANESTESIA CIRCUIT
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PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
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PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·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 |
| 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 |
| K896825 | TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR | Nov 16, 1990 | Substantially Equivalent |