The following data is part of a premarket notification filed by Tamarac Systems Corp. with the FDA for Presto Diagnostic Spirometer.
| Device ID | K894997 |
| 510k Number | K894997 |
| Device Name: | PRESTO DIAGNOSTIC SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | TAMARAC SYSTEMS CORP. 4890 IRONTON ST., SUITE 6L Denver, CO 80239 |
| Contact | Connelly-lynn |
| Correspondent | Connelly-lynn 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 | 1989-08-08 |
| Decision Date | 1989-10-30 |