FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WEISS EMERGENCY AIRWAY SYSTEM
K Number: K790650
·
Decision Jun 27, 1979
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
12
Review Days
85
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Basic Information
- Device Name
- WEISS EMERGENCY AIRWAY SYSTEM
- K Number
- K790650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5090
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Medical Devices , Ltd.
- Date Received
- April 3, 1979
- Decision Date
- June 27, 1979
- Product Code
- BWC
- 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 |
|---|---|---|---|
| BWC | Needle, Emergency Airway | FDA class 2 | Anesthesiology |
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Other Clearances by Intl. Medical Devices , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K913540 | PEDIA-THOR THORACOSTOMY KIT | Apr 9, 1992 | Substantially Equivalent |
| K913541 | NEO-THOR THORACOSTOMY KIT | Apr 9, 1992 | Substantially Equivalent |
| K913539 | THORACIC CATHTER STYLET | Jan 21, 1992 | Substantially Equivalent |
| K913542 | THORACIC CATHETER WITH GUIDE | Jan 21, 1992 | Substantially Equivalent |
| K913543 | THORACIC CATHETER STYLET | Oct 4, 1991 | Substantially Equivalent |
| K862909 | RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM | Sep 9, 1986 | Substantially Equivalent |
| K850398 | NU-CATH EMERGENCY KIT | Mar 27, 1985 | Substantially Equivalent |
| K843785 | WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR | Oct 23, 1984 | Substantially Equivalent |
| K842666 | NU-THOR THORACOSTOMY KIT | Sep 20, 1984 | Substantially Equivalent |
| K840925 | PEDIA-TRAKE CRICOTHYROTOMY KIT | May 2, 1984 | Substantially Equivalent |