510(k) K091732
K091732 is an FDA 510(k) premarket notification submitted by Deep Breeze , Ltd. for the device "VRLXP, MODEL XP". The FDA issued a decision of Substantially Equivalent on March 4, 2010. The device falls under product code OCR (Lung Sound Monitor), a Class II device regulated under 21 CFR 870.1875. Deep Breeze , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2010
- Date Received
- June 11, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lung Sound Monitor
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- AN
- Submission Type
The lung sound monitor is intended for use in monitoring and recording lung sounds.