The following data is part of a premarket notification filed by Camntech, Ltd with the FDA for Actiwave 1e, Actiwave2e, Actiwave2m, Actiwave4e, Actiwave Cardio Model 08-514, 08-521, 08-536, 08-557, 08-603.
| Device ID | K100266 |
| 510k Number | K100266 |
| Device Name: | ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | CAMNTECH, LTD UPPER PENDRILL COURT Papworth Everard, Cambridgeshi, GB Cb233uy |
| Contact | Howard Smith |
| Correspondent | Howard Smith CAMNTECH, LTD UPPER PENDRILL COURT Papworth Everard, Cambridgeshi, GB Cb233uy |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-29 |
| Decision Date | 2010-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B329AWVM33 | K100266 | 000 |
| B329AWVC23 | K100266 | 000 |
| B329AWV04E22 | K100266 | 000 |
| B329AWV02M25 | K100266 | 000 |
| B329AWV02E25 | K100266 | 000 |
| B329AWV01E22 | K100266 | 000 |