FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
K Number: K904556
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
432
Review Days
439
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Basic Information
- Device Name
- MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
- K Number
- K904556
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Boston Scientific Corp
- Date Received
- October 5, 1990
- Decision Date
- December 18, 1991
- Product Code
- IOL
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOL | Treadmill, Powered | FDA class 1 | Physical Medicine |
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