FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREATHING BAGS
K Number: K932581
·
Decision Jul 16, 1993
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
18
Applicant Total
17
Review Days
50
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Basic Information
- Device Name
- BREATHING BAGS
- K Number
- K932581
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-Plastics Intl., Inc.
- Date Received
- May 27, 1993
- Decision Date
- July 16, 1993
- Product Code
- BTC
- 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 |
|---|---|---|---|
| BTC | Bag, Reservoir | FDA class 1 | Anesthesiology |
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Other Clearances by Med-Plastics Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Jun 8, 1995 | Substantially Equivalent |
| K942570 | MAPLESON D CIRCUIT | Jun 10, 1994 | Substantially Equivalent |
| K942571 | HYPER-INFLATION BAG | Jun 10, 1994 | Substantially Equivalent |
| K942569 | VENTILATOR HOSE | Jun 10, 1994 | Substantially Equivalent |
| K942572 | VOLUME VENTILATOR | Jun 10, 1994 | Substantially Equivalent |
| K942568 | ADULT ANESTHESIA BREATHING CIRCUIT | Jun 10, 1994 | Substantially Equivalent |
| K942567 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | Jun 10, 1994 | Substantially Equivalent |
| K932575 | ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Jul 22, 1993 | Substantially Equivalent |
| K932578 | ADULT GAS SAMPLING CIRCUITS | Jul 22, 1993 | Substantially Equivalent |
| K932576 | PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Jul 22, 1993 | Substantially Equivalent |