Sensor, Respiration

GUDID 07540191000197

Technologie de Pensée Ltée

Biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system Psychophysiological biofeedback system

• Primary Device ID: 07540191000197
• NIH Device Record Key: bf564bec-a583-43d3-a45a-1a9db5d80af9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensor, Respiration
• Version Model Number: SA9311M
• Company DUNS: 209284132
• Company Name: Technologie de Pensée Ltée
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540191000197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903497

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-20
• Device Publish Date: 2017-08-31

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• 07540191000616 - Vaginal Pressure Probe: 2022-03-31
• 07540191000555 - MyOnyx: 2020-07-24
• 07540191000562 - NEUROINFINITI 2: 2020-07-24