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
129
Registration Numbers
129
Same Product Code
349
Applicant Total
19
Review Days
43
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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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Other Clearances by Medasonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991441 | CADENCE DOPPLER ULTRASOUND SYSTEM | Dec 28, 1999 | Substantially Equivalent |
| K962796 | NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM | Jan 21, 1997 | Substantially Equivalent |
| K961116 | FIRST BEAT/CARDIO BEAT/CALC | Aug 8, 1996 | Substantially Equivalent |
| 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 |
| K872292 | TRANSPECT TRANSCRANIAL DOPPLER | Aug 14, 1987 | Substantially Equivalent |
| 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 |