FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
K Number: K890822
·
Decision May 5, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
22
Review Days
77
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Basic Information
- Device Name
- CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
- K Number
- K890822
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ventlab Corp.
- Date Received
- February 17, 1989
- Decision Date
- May 5, 1989
- 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
FDA 510(k)
FDA Class 1
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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
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