FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
KNIGHTSTAR 330 VENTILATOR
K Number: K003075
·
Decision Dec 11, 2001
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
24
Applicant Total
2
Review Days
434
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Basic Information
- Device Name
- KNIGHTSTAR 330 VENTILATOR
- K Number
- K003075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Mallinckrodt, Inc.
- Date Received
- October 3, 2000
- Decision Date
- December 11, 2001
- Product Code
- MNT
- 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 |
|---|---|---|---|
| MNT | Sv70 Ventilator | FDA class 2 | Anesthesiology |
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Other Clearances by Mallinckrodt, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003315 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | Nov 8, 2000 | Substantially Equivalent |