FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECSCOPE 200
K Number: K091397
·
Decision Jul 8, 2009
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
14
Review Days
57
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Basic Information
- Device Name
- ECSCOPE 200
- K Number
- K091397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dyansys, Inc.
- Date Received
- May 12, 2009
- Decision Date
- July 8, 2009
- Product Code
- DPS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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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| K173861 | Drug Relief | May 2, 2018 | Substantially Equivalent |
| K170391 | ANSiStim-PP | Mar 9, 2017 | Substantially Equivalent |
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