The following data is part of a premarket notification filed by Lms Medical Systems (canada), Ltd. with the FDA for Calm Curve, Version 01.00.
| Device ID | K052715 |
| 510k Number | K052715 |
| Device Name: | CALM CURVE, VERSION 01.00 |
| Classification | System, Monitoring, Perinatal |
| Applicant | LMS MEDICAL SYSTEMS (CANADA), LTD. 5252 DE MAISONNEUVE WEST, #314 Montreal, Qc, CA H4a 3s5 |
| Contact | Pamela Haswell |
| Correspondent | Pamela Haswell LMS MEDICAL SYSTEMS (CANADA), LTD. 5252 DE MAISONNEUVE WEST, #314 Montreal, Qc, CA H4a 3s5 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2005-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B087PWCURV02101 | K052715 | 000 |
| B087CURV202411 | K052715 | 000 |
| B087CURV202221 | K052715 | 000 |
| B087CURV22011 | K052715 | 000 |
| B087CURV21011 | K052715 | 000 |
| B087CURV02121 | K052715 | 000 |
| B087CURV02061 | K052715 | 000 |
| B087CURV02081 | K052715 | 000 |
| B087CURV02101 | K052715 | 000 |
| B087CURVE02081 | K052715 | 000 |
| B087CURV202421 | K052715 | 000 |