Actiwave 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, Actiwave Cardio Model 08-514, 08-521, 08-536, 08-557, 08-603
FDA 510(k) K100266 · Camntech, Ltd.
510(k) numberK100266
Submission
- Device name
- Actiwave 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, Actiwave Cardio Model 08-514, 08-521, 08-536, 08-557, 08-603
- Applicant
- Camntech, Ltd.
Papworth Everard, Cambridgeshire, GB - Received
- January 29, 2010
- Decision date
- April 29, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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Questions and answers
When was Actiwave 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, Actiwave Cardio Model 08-514, 08-521, 08-536, 08-557, 08-603 cleared by the FDA?
Actiwave 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, Actiwave Cardio Model 08-514, 08-521, 08-536, 08-557, 08-603 (K100266) received a 510(k) decision of Substantially Equivalent on April 29, 2010, 90 days after the submission was received.
What is the product code of K100266?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.