FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRIMA BREATHING BAGS
K Number: K952011
·
Decision May 22, 1995
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
19
Review Days
24
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Basic Information
- Device Name
- PRIMA BREATHING BAGS
- K Number
- K952011
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prima, Inc.
- Date Received
- April 28, 1995
- Decision Date
- May 22, 1995
- 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
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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 VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
INFANT FLOW SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Prima, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952018 | PRIMA COAXIAL CIRCUITS | May 22, 1995 | Substantially Equivalent |
| K952015 | PRIMA FILTER | May 22, 1995 | Substantially Equivalent |
| K952010 | PRIMA VENTILATOR HOSES | May 22, 1995 | Substantially Equivalent |
| K952012 | PRIMA CUSTOM ANESTESIA CIRCUIT | May 22, 1995 | Substantially Equivalent |
| K952013 | PRIMA GUEDEL AIRWAYS | May 22, 1995 | Substantially Equivalent |
| K952021 | PRIMA HYUPERINFLATION SYSTEM | May 22, 1995 | Substantially Equivalent |
| K952019 | PRIMA ADULT GAS SAMPLING CIRCUITS | May 22, 1995 | Substantially Equivalent |
| K952020 | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | May 22, 1995 | Substantially Equivalent |
| K952014 | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | May 22, 1995 | Substantially Equivalent |
| K952017 | PRIMA MAPLESON D CIRCUIT | May 22, 1995 | Substantially Equivalent |