FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603
K Number: K100266
·
Decision Apr 29, 2010
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
59
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603
- K Number
- K100266
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Camntech, Ltd.
- Date Received
- January 29, 2010
- Decision Date
- April 29, 2010
- 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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Other Clearances by Camntech, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K132764 | MOTION WATCH AND PRO-DIARY | Jan 21, 2014 | Substantially Equivalent |