The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Spirometrics Model 2200 Sm200 Flow Sensor.
| Device ID | K884464 |
| 510k Number | K884464 |
| Device Name: | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR |
| Classification | Pneumotachometer |
| Applicant | SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Contact | Allen G Cyr |
| Correspondent | Allen G Cyr SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Product Code | JAX |
| CFR Regulation Number | 868.2550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-24 |
| Decision Date | 1989-01-19 |