The following data is part of a premarket notification filed by Tamarac Systems Corp. with the FDA for Rs232 Flow Sensor And Software Package.
| Device ID | K894680 |
| 510k Number | K894680 |
| Device Name: | RS232 FLOW SENSOR AND SOFTWARE PACKAGE |
| Classification | Spirometer, Diagnostic |
| Applicant | TAMARAC SYSTEMS CORP. 4890 IRONTON ST., SUITE 6L Denver, CO 80239 |
| Contact | Marilyn Connelly-lyn |
| Correspondent | Marilyn Connelly-lyn TAMARAC SYSTEMS CORP. 4890 IRONTON ST., SUITE 6L Denver, CO 80239 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-25 |
| Decision Date | 1989-10-23 |