FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K Number: K902405
·
Decision Mar 4, 1991
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
43
Review Days
277
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Basic Information
- Device Name
- MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
- K Number
- K902405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mallinckrodt Medical
- Date Received
- May 31, 1990
- Decision Date
- March 4, 1991
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Dec 29, 1997 | Substantially Equivalent |
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| K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | Jun 26, 1997 | Substantially Equivalent |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mar 28, 1997 | Substantially Equivalent |
| K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | Mar 20, 1997 | Substantially Equivalent |
| K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | Nov 26, 1996 | Substantially Equivalent |
| K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | Oct 4, 1996 | Substantially Equivalent |
| K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | Mar 13, 1996 | Substantially Equivalent |