FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZAK-2000
K Number: K972022
·
Decision Jan 22, 1998
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
9
Review Days
234
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Basic Information
- Device Name
- ZAK-2000
- K Number
- K972022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardio Systems, Inc.
- Date Received
- June 2, 1997
- Decision Date
- January 22, 1998
- Product Code
- FNM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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SIMPULSE
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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BARIAIR
FDA 510(k)
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| K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET | Nov 13, 1979 | Substantially Equivalent |
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