DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100

Monitor, Breathing Frequency

DYMEDIX, INC.

The following data is part of a premarket notification filed by Dymedix, Inc. with the FDA for Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 And Dymedix Reusable Limb Movement Sensor, Model 3100.

Pre-market Notification Details

• Device ID: K040605
• 510k Number: K040605
• Device Name: DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
• Classification: Monitor, Breathing Frequency
• Applicant: DYMEDIX, INC. 800 LEVANGER LN. Stoughton, WI 53589
• Contact: Gary Syring
• Correspondent: Gary Syring; DYMEDIX, INC. 800 LEVANGER LN. Stoughton, WI 53589
• Product Code: BZQ
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-03-08
• Decision Date: 2004-04-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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