FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCOLE 300 ECG RECORDER
K Number: K923664
·
Decision Jan 13, 1994
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
4
Review Days
540
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Basic Information
- Device Name
- SCOLE 300 ECG RECORDER
- K Number
- K923664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scole Engineering Co.
- Date Received
- July 22, 1992
- Decision Date
- January 13, 1994
- 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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