The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Smartrecorder, Model 2500.
| Device ID | K990199 |
| 510k Number | K990199 |
| Device Name: | SMARTRECORDER, MODEL 2500 |
| Classification | Ventilatory Effort Recorder |
| Applicant | RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-04-19 |
| Summary: | summary |