CALM

System, Monitoring, Perinatal

LMS MEDICAL SYSTEMS LTD.

The following data is part of a premarket notification filed by Lms Medical Systems Ltd. with the FDA for Calm.

Pre-market Notification Details

• Device ID: K980719
• 510k Number: K980719
• Device Name: CALM
• Classification: System, Monitoring, Perinatal
• Applicant: LMS MEDICAL SYSTEMS LTD. 5252 DE MAISONNEUVE WEST, #314 Montreal, Qc, CA H4a 3s5
• Contact: Dr. Emily Hamilton
• Correspondent: Dr. Emily Hamilton; 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: 1998-02-24
• Decision Date: 1998-07-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B087HUB01041	K980719	000
B087HUB202221	K980719	000
B087HUB22011	K980719	000
B087HUB21011	K980719	000
B087HUB01051	K980719	000
B087HUB01001	K980719	000
B087HUB01011	K980719	000
B087HUB01021	K980719	000
B087HUB01031	K980719	000
B087TRAC03181	K980719	000
B087VIGILANCE01001	K980719	000
B087HUB202411	K980719	000