FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PIGGYBACK BREATHING CIRCUIT
K Number: K791034
·
Decision Jun 15, 1979
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
75
Review Days
10
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Basic Information
- Device Name
- PIGGYBACK BREATHING CIRCUIT
- K Number
- K791034
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vital Signs, Inc.
- Date Received
- June 5, 1979
- Decision Date
- June 15, 1979
- 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)
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PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
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| K001553 | BREAS PV 100 CPAP SYSTEM | Aug 3, 2000 | Substantially Equivalent |
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| K994044 | CLEEN-ABLE | Feb 25, 2000 | Substantially Equivalent |
| K990412 | CUFF-ABLE PLUS | Sep 1, 1999 | Substantially Equivalent |