FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
K Number: K944534
·
Decision Nov 29, 1994
Classifications
1
FEI Numbers
161
Registration Numbers
161
Same Product Code
93
Applicant Total
19
Review Days
75
Basic Information
- Device Name
- PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
- K Number
- K944534
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PRIMA, INC.
- Date Received
- September 15, 1994
- Decision Date
- November 29, 1994
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K952021 | PRIMA HYUPERINFLATION SYSTEM | May 22, 1995 | Substantially Equivalent |
| K952019 | PRIMA ADULT GAS SAMPLING CIRCUITS | May 22, 1995 | Substantially Equivalent |
| K952010 | PRIMA VENTILATOR HOSES | May 22, 1995 | Substantially Equivalent |
| K952017 | PRIMA MAPLESON D CIRCUIT | May 22, 1995 | Substantially Equivalent |
| K952013 | PRIMA GUEDEL AIRWAYS | May 22, 1995 | Substantially Equivalent |
| K952014 | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | May 22, 1995 | Substantially Equivalent |
| K952012 | PRIMA CUSTOM ANESTESIA CIRCUIT | May 22, 1995 | Substantially Equivalent |