The following data is part of a premarket notification filed by Camntech, Ltd with the FDA for Motion Watch And Pro-diary.
| Device ID | K132764 |
| 510k Number | K132764 |
| Device Name: | MOTION WATCH AND PRO-DIARY |
| Classification | Device, Sleep Assessment |
| Applicant | CAMNTECH, LTD UPPER PENDRILL COURT Papworth Everard, Cambridgeshire, GB Cb233uy |
| Contact | Howard Smith |
| Correspondent | Howard Smith CAMNTECH, LTD UPPER PENDRILL COURT Papworth Everard, Cambridgeshire, GB Cb233uy |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-04 |
| Decision Date | 2014-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B329PDM25 | K132764 | 000 |
| B329MWR50 | K132764 | 000 |
| B329MW850 | K132764 | 000 |
| B329PDV25 | K132764 | 000 |