FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
K Number: K853737
·
Decision Feb 13, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
14
Review Days
160
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Basic Information
- Device Name
- VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
- K Number
- K853737
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1410
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Capintec, Inc.
- Date Received
- September 6, 1985
- Decision Date
- February 13, 1986
- Product Code
- IYY
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYY | Synchronizer, Electrocardiograph, Nuclear | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYY), ordered by most recent decision date.
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FDA 510(k)
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