The following data is part of a premarket notification filed by Stethographics, Inc. with the FDA for Stg Multichannel Lung Sound Analysis System.
| Device ID | K012387 |
| 510k Number | K012387 |
| Device Name: | STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | STETHOGRAPHICS, INC. 11874 S. EVELYN CIRCLE Houston, TX 77071 |
| Contact | Harvey Knauss |
| Correspondent | Harvey Knauss STETHOGRAPHICS, INC. 11874 S. EVELYN CIRCLE Houston, TX 77071 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-27 |
| Decision Date | 2002-04-23 |
| Summary: | summary |