FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
K Number: K932711
·
Decision Jul 23, 1993
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
16
Review Days
49
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Basic Information
- Device Name
- PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
- K Number
- K932711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precision Med Products, Ltd.
- Date Received
- June 4, 1993
- Decision Date
- July 23, 1993
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Precision Med Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K932710 | GAS SAMPLING LINES AND CONNECTORS | Jul 23, 1993 | Substantially Equivalent |
| K932707 | ADULT ANESTHESIA BREATHING CIRCUIT | Jul 23, 1993 | Substantially Equivalent |
| K932706 | PRECISION MED PRODUCTS LTD. VENTILATOR HOSE | Jul 23, 1993 | Substantially Equivalent |
| K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM | Jul 23, 1993 | Substantially Equivalent |
| K932708 | PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS | Jul 23, 1993 | Substantially Equivalent |
| K932488 | PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS | Jul 22, 1993 | Substantially Equivalent |
| K932489 | PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. | Jul 22, 1993 | Substantially Equivalent |
| K932712 | PRECISION MED PRODUCTS LTD VOLUME VENTILATORS | Jul 22, 1993 | Substantially Equivalent |
| K932497 | PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING | Jul 22, 1993 | Substantially Equivalent |
| K932486 | PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT | Jul 21, 1993 | Substantially Equivalent |