510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OCRClass II

Lung Sound Monitor

21 CFR 870.1875 / Cardiovascular
FDA source (opens on fda.gov)

OCR is the FDA product code for Lung Sound Monitor, a class II device type, regulated under 21 CFR 870.1875. FDA's definition for this code reads: "The lung sound monitor is intended for use in monitoring and recording lung sounds". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OCR
Device name
Lung Sound Monitor
FDA definition
The lung sound monitor is intended for use in monitoring and recording lung sounds.
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code OCR

By decision year
3 clearances under product code OCR with a decision year between 2007 and 2010, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OCR by decision year
YearClearances
20071
20081
20101

Applicants with the most clearances

Product code OCR
Applicants holding the most 510(k) clearances under product code OCR
ApplicantClearances
Deep Breeze, Ltd.3

Companies listing this code with FDA

Companies whose registered establishments list this code