The following data is part of a premarket notification filed by Tamarac Systems Corp. with the FDA for Peaklog And Display Software.
| Device ID | K940836 |
| 510k Number | K940836 |
| Device Name: | PEAKLOG AND DISPLAY SOFTWARE |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | TAMARAC SYSTEMS CORP. 4890 IRONTON ST., SUITE 6L Denver, CO 80239 |
| Contact | Marcie Connelly |
| Correspondent | Marcie Connelly TAMARAC SYSTEMS CORP. 4890 IRONTON ST., SUITE 6L Denver, CO 80239 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-23 |
| Decision Date | 1994-11-01 |