FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K Number: K852574
·
Decision Mar 13, 1986
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
104
Review Days
268
Basic Information
- Device Name
- WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
- K Number
- K852574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- WELCH ALLYN, INC.
- Date Received
- June 18, 1985
- Decision Date
- March 13, 1986
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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