FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEAN CUFF BLOOD PRESSURE CUFF LINER
K Number: K925352
·
Decision Jan 12, 1993
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
6
Review Days
82
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Basic Information
- Device Name
- CLEAN CUFF BLOOD PRESSURE CUFF LINER
- K Number
- K925352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Steridyne Corp.
- Date Received
- October 22, 1992
- Decision Date
- January 12, 1993
- Product Code
- DXQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
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Other Clearances by Steridyne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | May 30, 1991 | Substantially Equivalent |
| K911269 | MERCURY AND GLASS FEVER THERMOMETER | May 15, 1991 | Substantially Equivalent |
| K842120 | ZERO-G | Jun 8, 1984 | Substantially Equivalent |
| K821314 | FEVER METER | May 28, 1982 | Substantially Equivalent |
| K801458 | WINTER HEAD DRESSING | Jul 28, 1980 | Substantially Equivalent |