FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEQUENTIAL CUFF INFLATION DEVICE
K Number: K781358
·
Decision Sep 20, 1978
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
341
Applicant Total
19
Review Days
43
Basic Information
- Device Name
- SEQUENTIAL CUFF INFLATION DEVICE
- K Number
- K781358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MEDASONICS, INC.
- Date Received
- August 8, 1978
- Decision Date
- September 20, 1978
- Product Code
- JOW
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K914862 | CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS | Dec 3, 1992 | Substantially Equivalent |
| K911453 | OBTRASOUND STETHOSCOPE FETAL CALC | Jun 20, 1991 | Substantially Equivalent |
| K882018 | MEDACORD PVL, PERSONAL VASCULAR LABORATORY | Sep 21, 1988 | Substantially Equivalent |
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| K854734 | MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE | Feb 10, 1986 | Substantially Equivalent |
| K833588 | VASCULAR LABORATORY TREADMILL VT1 | Nov 14, 1983 | Substantially Equivalent |
| K837481 | BF24 DOPPLER MODEL P872 AND P874 | Jun 24, 1983 | Substantially Equivalent |