FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
K Number: K884421
·
Decision Jan 13, 1989
Classifications
1
FEI Numbers
175
Registration Numbers
175
Same Product Code
192
Applicant Total
17
Review Days
85
Basic Information
- Device Name
- PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
- K Number
- K884421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- PYMAH CORP.
- Date Received
- October 20, 1988
- Decision Date
- January 13, 1989
- 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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