The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Cmd/dlco Diagnostic Spirometer.
| Device ID | K911358 |
| 510k Number | K911358 |
| Device Name: | CMD/DLCO DIAGNOSTIC SPIROMETER |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| 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 | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-07-22 |