The following data is part of a premarket notification filed by Healthdyne Technologies, Inc. with the FDA for Simon Multichannel Recording System, Model 5500.
| Device ID | K983572 |
| 510k Number | K983572 |
| Device Name: | SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 |
| Classification | Ventilatory Effort Recorder |
| Applicant | HEALTHDYNE TECHNOLOGIES, INC. 1255 KENNESTONE CIR. Marietta, GA 30066 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni HEALTHDYNE TECHNOLOGIES, INC. 1255 KENNESTONE CIR. Marietta, GA 30066 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-03-19 |
| Summary: | summary |