FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATIENT BREATHING CIRCUIT
K Number: K843036
·
Decision Aug 15, 1984
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
20
Review Days
13
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
- PATIENT BREATHING CIRCUIT
- K Number
- K843036
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Infrasonics Corp.
- Date Received
- August 2, 1984
- Decision Date
- August 15, 1984
- 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
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA CUSTOM ANESTESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
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 |
| 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 |