510(k) K012387
K012387 is an FDA 510(k) premarket notification submitted by Stethographics, Inc. for the device "STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 23, 2002. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Stethographics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2002
- Date Received
- July 27, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Interpretor (Diagnostic)
- Device Class
- Class II
- Regulation Number
- 868.1900
- Review Panel
- AN
- Submission Type