The following data is part of a premarket notification filed by Lms Medical Systems Ltd. with the FDA for Calm Patterns, Version 01.00.00.
| Device ID | K040788 |
| 510k Number | K040788 |
| Device Name: | CALM PATTERNS, VERSION 01.00.00 |
| Classification | System, Monitoring, Perinatal |
| Applicant | LMS MEDICAL SYSTEMS LTD. 5252 DE MAISONNEUVE WEST, #314 Montreal, Qc, CA H4a 3s5 |
| Contact | Pamela J Haswell |
| Correspondent | Pamela J Haswell LMS MEDICAL SYSTEMS LTD. 5252 DE MAISONNEUVE WEST, #314 Montreal, Qc, CA H4a 3s5 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2005-02-08 |
| Summary: | summary |