FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUTAPE 24
K Number: K760508
·
Decision Aug 30, 1976
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
5
Review Days
6
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Basic Information
- Device Name
- ACCUTAPE 24
- K Number
- K760508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medcraft Corp.
- Date Received
- August 24, 1976
- Decision Date
- August 30, 1976
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 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 |
| K791795 | COMP-ACT IV | Sep 27, 1979 | Substantially Equivalent |
| K760510 | MONITORING SYSTEM, REHABILITATION | Aug 30, 1976 | Substantially Equivalent |
| K760509 | TREADMILL, DIAGNOSTIC | Aug 30, 1976 | Substantially Equivalent |