FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONNECTORS AND AIRWAY EXTENSIONS
K Number: K931036
·
Decision Apr 8, 1993
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
17
Review Days
38
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Basic Information
- Device Name
- CONNECTORS AND AIRWAY EXTENSIONS
- K Number
- K931036
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Life Shield Healthcare Products, Inc.
- Date Received
- March 1, 1993
- Decision Date
- April 8, 1993
- 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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Other Clearances by Life Shield Healthcare Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932562 | GAS SAMPLING LINES AND CONNECTORS | Jul 23, 1993 | Substantially Equivalent |
| K932561 | GUEDEL AIRWAYS | Jul 22, 1993 | Substantially Equivalent |
| K932557 | HYPERINFLATION SYSTEM | Jul 22, 1993 | Substantially Equivalent |
| K932560 | VOLUME VENTILATORS | Jul 22, 1993 | Substantially Equivalent |
| K932558 | ADULT ANESTHESIA BREATHING CIRCUIT | Jul 22, 1993 | Substantially Equivalent |
| K932559 | MAPLESON D CIRCUITS | Jul 16, 1993 | Substantially Equivalent |
| K932563 | VENTILATOR HOSES | Jul 16, 1993 | Substantially Equivalent |
| K932191 | BREATHING BAGS | Jul 2, 1993 | Substantially Equivalent |
| K932193 | PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Jul 2, 1993 | Substantially Equivalent |
| K932195 | ADULT GAS SAMPLING CIRCUITS | Jul 2, 1993 | Substantially Equivalent |