FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZERO-G
K Number: K842120
·
Decision Jun 8, 1984
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
28
Applicant Total
6
Review Days
10
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Basic Information
- Device Name
- ZERO-G
- K Number
- K842120
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Steridyne Corp.
- Date Received
- May 29, 1984
- Decision Date
- June 8, 1984
- Product Code
- KIC
- 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 |
|---|---|---|---|
| KIC | Cushion, Flotation | FDA class 1 | Physical Medicine |
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Other Clearances by Steridyne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K925352 | CLEAN CUFF BLOOD PRESSURE CUFF LINER | Jan 12, 1993 | Substantially Equivalent |
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | May 30, 1991 | Substantially Equivalent |
| K911269 | MERCURY AND GLASS FEVER THERMOMETER | May 15, 1991 | Substantially Equivalent |
| K821314 | FEVER METER | May 28, 1982 | Substantially Equivalent |
| K801458 | WINTER HEAD DRESSING | Jul 28, 1980 | Substantially Equivalent |