FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHROMA, MODEL: RZ153C
K Number: K083382
·
Decision Aug 13, 2009
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
59
Applicant Total
4
Review Days
272
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Basic Information
- Device Name
- CHROMA, MODEL: RZ153C
- K Number
- K083382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scottcare Corporation
- Date Received
- November 14, 2008
- Decision Date
- August 13, 2009
- Product Code
- MWJ
- 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 |
|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | FDA class 2 | Cardiovascular |
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