The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Spirometrics Model 2600 Miro Spirometer.
| Device ID | K901057 |
| 510k Number | K901057 |
| Device Name: | SPIROMETRICS MODEL 2600 MIRO SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Contact | Ann M Therriault |
| Correspondent | Ann M Therriault SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-04-03 |