FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
K Number: K083677
·
Decision Mar 10, 2009
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
- K Number
- K083677
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Commwell , Ltd.
- Date Received
- December 11, 2008
- Decision Date
- March 10, 2009
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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