physIQ Heart Rhythm and Respiration Module
FDA 510(k)Class II (US FDA 510(k))
by Physiq, Inc
Identifiers
- 510(k) Number
- K193415 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The physIQ Heart Rhythm and Respiration Module is a medical device designed to monitor heart rhythm and respiration. It captures physiological data to provide insights into cardiovascular and respiratory functions.
This module is supplied for single-use and is not MRI safe. It is stored according to manufacturer guidelines and has received FDA 510(k) clearance with the product code DPS.
Frequently asked questions
What is the physIQ Heart Rhythm and Respiration Module used for?
The physIQ Heart Rhythm and Respiration Module is designed to monitor heart rhythm and respiration, capturing physiological data to provide insights into cardiovascular and respiratory functions for clinical assessment.
Is the physIQ Heart Rhythm and Respiration Module reusable or MRI safe?
This module is supplied for single-use only and is not MRI safe. It should be discarded after a single application according to medical waste disposal guidelines.
What regulatory approvals does the physIQ Heart Rhythm and Respiration Module have?
The module has received FDA 510(k) clearance with the product code DPS, classified under the cardiovascular advisory committee, indicating it is substantially equivalent to predicate devices.
How should the physIQ Heart Rhythm and Respiration Module be stored?
The module should be stored according to the manufacturer's guidelines to maintain its integrity and functionality until use, typically in a controlled environment away from extreme temperatures or humidity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193415 | Class II | Active |
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Manufacturer
- Manufacturer
- Physiq, Inc
- FDA Applicant
- Physiq, Inc.
Sources (1)
- FDA 510(k) K193415 24 fields · synced Sep 23, 2026