Identifiers
- 510(k) Number
- K132405 FDA 510(k)
- FDA Product Code
- DQD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1875 FDA 510(k)
- Regulation Number
- 870.1875 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PPA/BT-RB Stethoscope is an electronic stethoscope designed for detecting and amplifying heart, lung, and other body sounds for diagnostic or monitoring purposes on a patient. It is substantially equivalent to a predicate device and shares the same intended use, principles of operation, and technological characteristics as the auscultation function of that device.
The device is supplied by Rnk Products, Inc. and has received FDA 510(k) clearance under K-number K132405. It is classified as a Class II medical device with product code DQD and regulation number 870.1875. The device is intended for use in cardiovascular applications and is not described as sterile, single-use, reusable, MRI safe, or having specific sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance.
Frequently asked questions
What is the PPA/BT-RB Stethoscope used for?
The PPA/BT-RB Stethoscope is designed for detecting and amplifying heart, lung, and other body sounds to support diagnostic or monitoring purposes on a patient, particularly in cardiovascular applications.
How is the PPA/BT-RB Stethoscope supplied and by whom?
The device is supplied by Rnk Products, Inc. from their facility in Melbourne, Florida, and is provided as a finished electronic stethoscope for clinical use.
Is the PPA/BT-RB Stethoscope sterile, single-use, or reusable?
The device description does not state that the PPA/BT-RB Stethoscope is sterile, single-use, or reusable; no such claims are made in the provided data.
What regulatory pathway was used for the PPA/BT-RB Stethoscope?
The PPA/BT-RB Stethoscope received FDA 510(k) clearance under K-number K132405, indicating it is substantially equivalent to a predicate device.
What classification and product code apply to the PPA/BT-RB Stethoscope?
The device is classified as a Class II medical device with product code DQD and regulation number 870.1875, reflecting its placement in the cardiovascular specialty.
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. Sources consulted: PDF .RN( Products, Inc. - Food and Drug Administration, K132405 FDA 510(k) - PPA/BT-RB STETHOSCOPE | Rnk Products, Inc., Rnk Products, Inc. FDA 510 (k) Products (2007-2013), 510 (k) K132405 — PPA/BT-RB STETHOSCOPE — RegDataLab, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132405 | Class II | Active |
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Manufacturer
- Manufacturer
- Rnk Products, Inc.
Sources (1)
- FDA 510(k) K132405 24 fields · synced Sep 28, 2026