Lung Sound Monitor
The Lung Sound Monitor (product code OCR) is a cardiovascular/anesthesiology device intended for monitoring and recording lung sounds, enabling clinicians to assess respiratory function by capturing auscultatory data electronically. The device supports continuous or episodic monitoring of breath sounds for clinical decision-making. This device is FDA Class 2 under regulation 870.1875 in the Cardiovascular specialty, requiring 510(k) clearance through the De Novo pathway (submission type 4). It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCR
- Device Class
- FDA class 2
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
Definition
The lung sound monitor is intended for use in monitoring and recording lung sounds.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091732 | VRLXP, MODEL XP | Mar 04, 2010 | Substantially Equivalent | Deep Breeze , Ltd. |
| K073582 | VRIICU SYSTEM | Oct 15, 2008 | Substantially Equivalent | Deep Breeze , Ltd. |
| K061495 | VR LUNG ELECTROSONOGRAPH | Jul 18, 2007 | Substantially Equivalent | Deep Breeze , Ltd. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.