FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMP-ACT IV
K Number: K791795
·
Decision Sep 27, 1979
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
13
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Basic Information
- Device Name
- COMP-ACT IV
- K Number
- K791795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medcraft Corp.
- Date Received
- September 14, 1979
- Decision Date
- September 27, 1979
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Medcraft Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K860467 | ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 | Nov 10, 1986 | Substantially Equivalent |
| K760510 | MONITORING SYSTEM, REHABILITATION | Aug 30, 1976 | Substantially Equivalent |
| K760509 | TREADMILL, DIAGNOSTIC | Aug 30, 1976 | Substantially Equivalent |
| K760508 | ACCUTAPE 24 | Aug 30, 1976 | Substantially Equivalent |