510(k) K073582
K073582 is an FDA 510(k) premarket notification submitted by Deep Breeze , Ltd. for the device "VRIICU SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 2008. 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
- October 15, 2008
- Date Received
- December 20, 2007
- 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.