FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medline Singe Patient Use Blood Pressure Cuff
K Number: K161035
·
Decision Jun 13, 2016
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
238
Review Days
61
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Basic Information
- Device Name
- Medline Singe Patient Use Blood Pressure Cuff
- K Number
- K161035
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline Industries, Inc.
- Date Received
- April 13, 2016
- Decision Date
- June 13, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXQ), ordered by most recent decision date.
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
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